<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01730586</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0776</org_study_id>
    <secondary_id>NCI-2013-00077</secondary_id>
    <nct_id>NCT01730586</nct_id>
  </id_info>
  <brief_title>Abraxane in CIMP-High Colorectal and Small Bowel Adenocarcinomas</brief_title>
  <official_title>Phase II Study of Abraxane in CIMP-High Colorectal Adenocarcinomas and Small Bowel Adenocarcinomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this clinical research study is to learn if abraxane can help to control&#xD;
      colorectal and/or small bowel cancer. The safety of this drug will also be studied.&#xD;
&#xD;
      Abraxane is designed to block cancer cells from dividing, which may cause them to die.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Drug Administration:&#xD;
&#xD;
      If you are found to be eligible to take part in this study, you will receive the study drug&#xD;
      in 21-day study cycles.&#xD;
&#xD;
      You will receive abraxane by vein over about 30 minutes on Day 1 of each cycle.&#xD;
&#xD;
      Study Visits:&#xD;
&#xD;
      On Day 1 of all cycles, the following tests and procedures will be performed:&#xD;
&#xD;
        -  You will have a physical exam, including measurement of your weight and blood pressure.&#xD;
&#xD;
        -  You will be asked about any drugs you may be taking and about any symptoms or side&#xD;
           effects you may be having.&#xD;
&#xD;
        -  Your performance status will be recorded.&#xD;
&#xD;
        -  Blood (about 2 tablespoons) will be drawn for routine tests.&#xD;
&#xD;
      At the end of every 3rd cycle (Cycles 3, 6, 9) and so on:&#xD;
&#xD;
      °You will have a CT or MRI scan of your chest, abdomen, and pelvis to check the status of the&#xD;
      disease. If at any point the scans show the disease appearing to get better, you will have&#xD;
      another scan 2 cycles later.&#xD;
&#xD;
      Length of Treatment:&#xD;
&#xD;
      You may continue taking the study drug for as long as the doctor thinks it is in your best&#xD;
      interest. You will no longer be able to take the study drug if the disease gets worse, if you&#xD;
      have intolerable side effects, if the study is stopped, or if you are unable to follow study&#xD;
      instructions.&#xD;
&#xD;
      Your participation on the study will be over after the follow-up period.&#xD;
&#xD;
      End-of-Treatment Visit:&#xD;
&#xD;
      Within 10 days after you stop taking the study drug, you will have an end-of-treatment visit.&#xD;
      At this visit, the following tests and procedures will be performed:&#xD;
&#xD;
        -  You will have a physical exam, including measurement of your weight and blood pressure.&#xD;
&#xD;
        -  You will be asked about any drugs you may be taking and about any symptoms or side&#xD;
           effects you may be having.&#xD;
&#xD;
        -  Your performance status will be recorded.&#xD;
&#xD;
        -  Blood (about 2 tablespoons) will be drawn for routine tests.&#xD;
&#xD;
        -  If one has not been performed in the previous 4 weeks, you will have a CT or MRI scan of&#xD;
           your chest, abdomen, and pelvis to check the status of the disease.&#xD;
&#xD;
      Follow-Up:&#xD;
&#xD;
      The study staff will ask about any symptoms or side effects you may be having during the 30&#xD;
      days after your last dose of the study drugs. The study staff may ask you by phone or at the&#xD;
      time of a routine clinic visit. If the study staff contacts you by phone, the phone call&#xD;
      should last about 15-30 minutes.&#xD;
&#xD;
      If you leave the study for any reason other than the disease getting worse, you will have a&#xD;
      CT or MRI scan of your chest, abdomen, and pelvis to check the status of the disease every 12&#xD;
      weeks unless you start receiving other treatment.&#xD;
&#xD;
      The study staff will also review your medical records and/or contact you to check the status&#xD;
      of the disease every 3 months after you stop receiving the study drug. If you are contacted&#xD;
      by phone, each phone call should take about 5 minutes.&#xD;
&#xD;
      This is an investigational study. Abraxane is FDA approved and commercially available for the&#xD;
      treatment of breast cancer. It is not FDA approved for the treatment of colorectal or small&#xD;
      bowel cancer. The use of abraxane in patients with colorectal cancer or small bowel cancer is&#xD;
      investigational.&#xD;
&#xD;
      Up to 35 patients will take part in this study. All will be enrolled at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA)</measure>
    <time_frame>Assessed at 21 day cycle; Restaging done every 3 cycles</time_frame>
    <description>Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1, 2009): Complete Response (CR): Disappearance all lesions including normalization of elevated tumor marker level; Pathological lymph nodes reduction in short axis to &lt;10 mm. Partial Response (PR): &gt;30% decrease sum longest diameters (LD) of lesions reference baseline sum LD. Progressive Disease (PD): &gt;20% increase (absolute increase &gt;5 mm) in sum LD measured lesions references smallest sum LD, and appearance new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD. After a tumor demonstrates a tumor response (partial or complete), confirmation of the response obtained by a second evaluation to be performed 2 cycles later (+/- 1week) [second tumor assessment not &lt;4 weeks from response observed]. Assessed via computed tomography (CT) of the chest, abdomen, and pelvis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Assessed at first cycle (21 days), up to 12 months</time_frame>
    <description>The length of time during and after the treatment a participant lives without disease progression. Time to progression functions estimated using the Kaplan-Meier method. Participants who drop out of the study included in the time to event data analysis as &quot;censored data&quot;.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Cancer of Gastrointestinal Tract</condition>
  <arm_group>
    <arm_group_label>Abraxane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abraxane 220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abraxane</intervention_name>
    <description>220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days.</description>
    <arm_group_label>Abraxane</arm_group_label>
    <other_name>Nab-Paclitaxel</other_name>
    <other_name>Paclitaxel (Protein-Bound)</other_name>
    <other_name>ABI-007</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient must have histologically or cytologically confirmed colorectal adenocarcinoma&#xD;
             or small bowel adenocarcinoma&#xD;
&#xD;
          2. Metastatic disease documented on diagnostic imaging studies with measurable disease&#xD;
             per RECIST version 1.1.&#xD;
&#xD;
          3. Refractory disease defined as: a) prior treatment with fluoropyrimidine, oxaliplatin,&#xD;
             irinotecan, and anti-epidermal growth factor receptor (EGFR) therapy if Kirsten rat&#xD;
             sarcoma (KRAS) wildtype for colorectal adenocarcinoma and; b) prior treatment with&#xD;
             fluoropyrimidine and oxaliplatin for small bowel adenocarcinoma.&#xD;
&#xD;
          4. Colorectal adenocarcinoma patients must be known to have CpG island methylator&#xD;
             phenotype. CIMP-high phenotype will be defined as hypermethylation at 2 or more of the&#xD;
             6 methylation-specific PCR markers (hMLH1, P16, P14, MINT1, MINT2, and MINT31).&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.&#xD;
&#xD;
          6. Adequate organ function including: a) Absolute neutrophil count (ANC)&#xD;
             =/&gt;1,500cells/mm^3; b) Platelets =/&gt;100,000/ul; c) Hemoglobin &gt;9.0 g/dL; d) Total&#xD;
             bilirubin =/&lt;1.5mg/dL In patients with known Gilbert's syndrome, direct bilirubin&#xD;
             =/&lt;1.5 x upper limit of normal (ULN) will be used as organ function criteria, instead&#xD;
             of total bilirubin; e) AST and ALT &lt; 2.5 x ULN; f) Alkaline phosphatase &lt;2.5x ULN; g)&#xD;
             Creatinine &lt;1.5 gm/dL.&#xD;
&#xD;
          7. Negative serum or urine pregnancy test in women with childbearing potential (WOCBP)&#xD;
             defined as not post-menopausal for 12 months or no previous surgical sterilization,&#xD;
             within one week prior to initiation of treatment. WOCBP must be using an adequate&#xD;
             method of contraception to avoid pregnancy throughout the study and for up to 12 weeks&#xD;
             after the last dose of study drug to minimize the risk of pregnancy.&#xD;
&#xD;
          8. A male subject of fathering potential must use an adequate method of contraception to&#xD;
             avoid conception throughout the study and for up to 12 weeks after the last dose of&#xD;
             study drug to minimize the risk of pregnancy. If the partner is pregnant or&#xD;
             breastfeeding, the subject must use a condom.&#xD;
&#xD;
          9. Patients must sign an Informed Consent and Authorization indicating that they are&#xD;
             aware of the investigational nature of this study and the known risks involved.&#xD;
&#xD;
         10. Patient is =/&gt;18 years of age on the day of consenting to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse&#xD;
             Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as&#xD;
             &quot;moderate symptoms; limiting instrumental activities of daily living (ADLs)&quot;.&#xD;
&#xD;
          2. Prior treatment with taxane therapy for either colorectal cancer or small bowel&#xD;
             adenocarcinoma.&#xD;
&#xD;
          3. Chemotherapy or any other investigational agents within 14 days of first receipt of&#xD;
             study treatment, or major surgery within 28 days of first receipt of study treatment,&#xD;
             or palliative radiation within 7 days of first receipt of study treatment.&#xD;
&#xD;
          4. Concurrent severe and/or uncontrolled medical conditions which could compromise&#xD;
             participation in the study such as unstable angina, myocardial infarction within 6&#xD;
             months, unstable symptomatic arrhythmia, uncontrolled diabetes, serious active or&#xD;
             uncontrolled infection.&#xD;
&#xD;
          5. Pregnancy (positive pregnancy test) or lactation.&#xD;
&#xD;
          6. Patients with carcinomatous meningitis.&#xD;
&#xD;
          7. Known central nervous system (CNS) disease, except for treated brain metastasis.&#xD;
             Treated brain metastases are defined as having no evidence of progression or&#xD;
             hemorrhage after treatment and no ongoing requirement for dexamethasone, as&#xD;
             ascertained by clinical examination and brain imaging (MRI or CT) during the screening&#xD;
             period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may&#xD;
             include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or&#xD;
             equivalent) or a combination as deemed appropriate by the treating physician. Patients&#xD;
             with CNS metastases treated by neurosurgical resection or brain biopsy performed&#xD;
             within 3 months prior to Day 1 will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Overman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <results_first_submitted>May 2, 2019</results_first_submitted>
  <results_first_submitted_qc>January 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 18, 2020</results_first_posted>
  <last_update_submitted>January 9, 2020</last_update_submitted>
  <last_update_submitted_qc>January 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal Cancer</keyword>
  <keyword>Cancer of Gastrointestinal Tract</keyword>
  <keyword>CIMP-high Colorectal Adenocarcinoma</keyword>
  <keyword>Small Bowel Adenocarcinomas</keyword>
  <keyword>Colorectal</keyword>
  <keyword>Small bowel cancer</keyword>
  <keyword>Abraxane</keyword>
  <keyword>Nab-Paclitaxel</keyword>
  <keyword>Paclitaxel (Protein-Bound)</keyword>
  <keyword>ABI-007</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment Period: November 2012 to October 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Abraxane</title>
          <description>Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Inadequate Trial</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Hospice</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Abraxane</title>
          <description>Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="34"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59" lower_limit="34" upper_limit="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Colorectal Cancer Diagnosis</title>
          <description>Histologically or cytologically confirmed colorectal adenocarcinoma (CpG island methylator phenotype (CIMP-high)) or small bowel adenocarcinoma</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Small Bowel Adenocarcinoma (SBA)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>CIMP-high Colorectal Cancer (CRC)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA)</title>
        <description>Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1, 2009): Complete Response (CR): Disappearance all lesions including normalization of elevated tumor marker level; Pathological lymph nodes reduction in short axis to &lt;10 mm. Partial Response (PR): &gt;30% decrease sum longest diameters (LD) of lesions reference baseline sum LD. Progressive Disease (PD): &gt;20% increase (absolute increase &gt;5 mm) in sum LD measured lesions references smallest sum LD, and appearance new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD. After a tumor demonstrates a tumor response (partial or complete), confirmation of the response obtained by a second evaluation to be performed 2 cycles later (+/- 1week) [second tumor assessment not &lt;4 weeks from response observed]. Assessed via computed tomography (CT) of the chest, abdomen, and pelvis.</description>
        <time_frame>Assessed at 21 day cycle; Restaging done every 3 cycles</time_frame>
        <population>In the CIMP-CRC arm 15 participants were considered efficacy evaluable [Of 21 treated, 6 participants were withdrawn due to toxicity (2) and due to clinical progression (4)], and three were not evaluable in SBA arm.</population>
        <group_list>
          <group group_id="O1">
            <title>CIMP-high Colorectal Cancer</title>
            <description>Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Small Bowel Adenocarcinoma (SBA)</title>
            <description>Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA)</title>
          <description>Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1, 2009): Complete Response (CR): Disappearance all lesions including normalization of elevated tumor marker level; Pathological lymph nodes reduction in short axis to &lt;10 mm. Partial Response (PR): &gt;30% decrease sum longest diameters (LD) of lesions reference baseline sum LD. Progressive Disease (PD): &gt;20% increase (absolute increase &gt;5 mm) in sum LD measured lesions references smallest sum LD, and appearance new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD. After a tumor demonstrates a tumor response (partial or complete), confirmation of the response obtained by a second evaluation to be performed 2 cycles later (+/- 1week) [second tumor assessment not &lt;4 weeks from response observed]. Assessed via computed tomography (CT) of the chest, abdomen, and pelvis.</description>
          <population>In the CIMP-CRC arm 15 participants were considered efficacy evaluable [Of 21 treated, 6 participants were withdrawn due to toxicity (2) and due to clinical progression (4)], and three were not evaluable in SBA arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Complete Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progressive Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-Free Survival (PFS)</title>
        <description>The length of time during and after the treatment a participant lives without disease progression. Time to progression functions estimated using the Kaplan-Meier method. Participants who drop out of the study included in the time to event data analysis as &quot;censored data&quot;.</description>
        <time_frame>Assessed at first cycle (21 days), up to 12 months</time_frame>
        <population>For progression-free survival, the intent-to-treat analysis performed using all available participants.</population>
        <group_list>
          <group group_id="O1">
            <title>CIMP-high Colorectal Cancer</title>
            <description>Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Small Bowel Adenocarcinoma</title>
            <description>Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS)</title>
          <description>The length of time during and after the treatment a participant lives without disease progression. Time to progression functions estimated using the Kaplan-Meier method. Participants who drop out of the study included in the time to event data analysis as &quot;censored data&quot;.</description>
          <population>For progression-free survival, the intent-to-treat analysis performed using all available participants.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" lower_limit="1.7" upper_limit="2.5"/>
                    <measurement group_id="O2" value="3.2" lower_limit="2.6" upper_limit="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through Day 30 (Day 28 to Day 45 allowed) following the last dose of study drug or until resolution or stabilization of the toxicity or start of another treatment regimen, up to 3 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Abraxane</title>
          <description>Abraxane 220 mg/m^2 intravenously on Day 1 of 21 day cycle.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Jejunal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Rectal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Infection, Other - perirectal abcess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="15" subjects_affected="12" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred vision</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Eye disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="18" subjects_affected="9" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="12" subjects_affected="8" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="19" subjects_affected="10" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Duodenal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - (Other)</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Gastroparesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="24" subjects_affected="14" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Rectal pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="12" subjects_affected="8" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema face</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="39" subjects_affected="21" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Flu like symptoms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Localized edema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations - (Other)</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Investigations - (Other)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hyperuricemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="12" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Generalized muscle weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Joint range of motion decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Muscle weakness lower limb</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="28" subjects_affected="14" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="12" subjects_affected="7" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Concentration impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Reproductive system and breast disorders - (Other)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic rhinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hoarseness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Postnasal drip</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="26" subjects_affected="26" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Nail discoloration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pain of skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysesthesia syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Rash acneiform</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - (Other)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Skin hyperpigmentation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="9" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hot flashes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Michael Overman, Associate Professor, GI Medical Oncology</name_or_title>
      <organization>The University of Texas (UT) MD Anderson Cancer Center</organization>
      <phone>713-792-7734</phone>
      <email>MOverman@mdanderson.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01730586
org study id: 2012-0776
secondary id: NCI-2013-00077
nct id: NCT01730586
lead sponsor: 
collaborator: 
has dmc: No
The goal of this clinical research study is to learn if abraxane can help to control
      colorectal and/or small bowel cancer. The safety of this drug will also be studied.

      Abraxane is designed to block cancer cells from dividing, which may cause them to die.
Study Drug Administration:

      If you are found to be eligible to take part in this study, you will receive the study drug
      in 21-day study cycles.

      You will receive abraxane by vein over about 30 minutes on Day 1 of each cycle.

      Study Visits:

      On Day 1 of all cycles, the following tests and procedures will be performed:

        -  You will have a physical exam, including measurement of your weight and blood pressure.

        -  You will be asked about any drugs you may be taking and about any symptoms or side
           effects you may be having.

        -  Your performance status will be recorded.

        -  Blood (about 2 tablespoons) will be drawn for routine tests.

      At the end of every 3rd cycle (Cycles 3, 6, 9) and so on:

      °You will have a CT or MRI scan of your chest, abdomen, and pelvis to check the status of the
      disease. If at any point the scans show the disease appearing to get better, you will have
      another scan 2 cycles later.

      Length of Treatment:

      You may continue taking the study drug for as long as the doctor thinks it is in your best
      interest. You will no longer be able to take the study drug if the disease gets worse, if you
      have intolerable side effects, if the study is stopped, or if you are unable to follow study
      instructions.

      Your participation on the study will be over after the follow-up period.

      End-of-Treatment Visit:

      Within 10 days after you stop taking the study drug, you will have an end-of-treatment visit.
      At this visit, the following tests and procedures will be performed:

        -  You will have a physical exam, including measurement of your weight and blood pressure.

        -  You will be asked about any drugs you may be taking and about any symptoms or side
           effects you may be having.

        -  Your performance status will be recorded.

        -  Blood (about 2 tablespoons) will be drawn for routine tests.

        -  If one has not been performed in the previous 4 weeks, you will have a CT or MRI scan of
           your chest, abdomen, and pelvis to check the status of the disease.

      Follow-Up:

      The study staff will ask about any symptoms or side effects you may be having during the 30
      days after your last dose of the study drugs. The study staff may ask you by phone or at the
      time of a routine clinic visit. If the study staff contacts you by phone, the phone call
      should last about 15-30 minutes.

      If you leave the study for any reason other than the disease getting worse, you will have a
      CT or MRI scan of your chest, abdomen, and pelvis to check the status of the disease every 12
      weeks unless you start receiving other treatment.

      The study staff will also review your medical records and/or contact you to check the status
      of the disease every 3 months after you stop receiving the study drug. If you are contacted
      by phone, each phone call should take about 5 minutes.

      This is an investigational study. Abraxane is FDA approved and commercially available for the
      treatment of breast cancer. It is not FDA approved for the treatment of colorectal or small
      bowel cancer. The use of abraxane in patients with colorectal cancer or small bowel cancer is
      investigational.

      Up to 35 patients will take part in this study. All will be enrolled at MD Anderson.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA)
time frame: Assessed at 21 day cycle; Restaging done every 3 cycles
description: Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1, 2009): Complete Response (CR): Disappearance all lesions including normalization of elevated tumor marker level; Pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): >30% decrease sum longest diameters (LD) of lesions reference baseline sum LD. Progressive Disease (PD): >20% increase (absolute increase >5 mm) in sum LD measured lesions references smallest sum LD, and appearance new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD. After a tumor demonstrates a tumor response (partial or complete), confirmation of the response obtained by a second evaluation to be performed 2 cycles later (+/- 1week) [second tumor assessment not <4 weeks from response observed]. Assessed via computed tomography (CT) of the chest, abdomen, and pelvis.
measure: Progression-Free Survival (PFS)
time frame: Assessed at first cycle (21 days), up to 12 months
description: The length of time during and after the treatment a participant lives without disease progression. Time to progression functions estimated using the Kaplan-Meier method. Participants who drop out of the study included in the time to event data analysis as "censored data".
arm group label: Abraxane
arm group type: Experimental
description: Abraxane 220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days.
intervention type: Drug
intervention name: Abraxane
description: 220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days.
arm group label: Abraxane
other name: Nab-Paclitaxel
other name: Paclitaxel (Protein-Bound)
other name: ABI-007
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Overman, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Adenocarcinoma
mesh term: Gastrointestinal Neoplasms
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 