<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/NCT03026803</url>
  </required_header>
  <id_info>
    <org_study_id>05195</org_study_id>
    <nct_id>NCT03026803</nct_id>
  </id_info>
  <brief_title>A Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer</brief_title>
  <official_title>A Phase II Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City of Hope Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>City of Hope Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial is studying how well giving oxaliplatin and capecitabine together works&#xD;
      in treating patients with liver cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to&#xD;
      stop the growth of tumor cells, either by killing the cells or by stopping them from&#xD;
      dividing. Giving these drugs together may kill more tumor cells.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to Sorafenib became first line treatment for HCC, the designed treatment became less&#xD;
    competitive. The company Sanofi decided not to continue to support&#xD;
  </why_stopped>
  <start_date>November 2006</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Liver Cancer</condition>
  <condition>Hepatocellular Cancer</condition>
  <arm_group>
    <arm_group_label>Oxaliplatin and Capecitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>21 day cycle with Oxaliplatin 50mg/m2 day 1 and day 8 administered IV, Capecitabine 750 mg/m2 bid p.o. daily from day 1 to day 14</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Oxaliplatin and Capecitabine</arm_group_label>
    <other_name>Eloxatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Oxaliplatin and Capecitabine</arm_group_label>
    <other_name>Xeloda</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically confirmed hepatocellular carcinoma which is&#xD;
             recurrent, metastatic or unresectable.&#xD;
&#xD;
          -  Patients may have up to two prior chemotherapy regimes. In addition, they may have had&#xD;
             previous radiation, chemoembolization, and/or alcohol injections.&#xD;
&#xD;
          -  Patients must have measurable disease, defined as lesions that can be accurately&#xD;
             measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with&#xD;
             conventional techniques or as ≥10 mm with spiral CT scan, and which has clearly&#xD;
             progressed during the observation interval prior to participation in this study.&#xD;
             Pleural effusions and ascites will not be considered measurable, but may be present in&#xD;
             addition to the measurable lesion(s).&#xD;
&#xD;
          -  Karnofsky performance status &gt; 70%.&#xD;
&#xD;
          -  Patients should have an expected survival of at least 2 months.&#xD;
&#xD;
          -  Leukocytes &gt;3,000/µl&#xD;
&#xD;
          -  Absolute neutrophil count &gt;1,500/µl&#xD;
&#xD;
          -  Platelets &gt;50,000/µl&#xD;
&#xD;
          -  Total bilirubin &lt; 3.0 g/dl&#xD;
&#xD;
          -  AST (aspartate aminotransferase) (serum glutamic oxaloacetic transaminase(SGOT)/ALT&#xD;
             (alanine aminotransferase) (serum glutamic pyruvic transaminase)(SGPT) &lt; 5 times&#xD;
             institutional upper limit of normal&#xD;
&#xD;
          -  Creatinine &lt; 2.0 OR measured or calculated creatinine clearance &gt;60 mL/min for&#xD;
             patients with creatinine levels above institutional normal&#xD;
&#xD;
          -  Brain metastasis is not an exclusion, however, patients are only eligible if they have&#xD;
             had successful control of the brain tumor(s) by surgery or stereotactic RT.&#xD;
&#xD;
          -  Patients with no evidence of clinically significant neuropathy.&#xD;
&#xD;
          -  All prior therapy must have been completed at least 4 weeks prior to the patient's&#xD;
             entry on this trial.&#xD;
&#xD;
          -  Women of childbearing potential and men must agree to use adequate contraception&#xD;
             (hormonal or barrier method of birth control) prior to study entry and for the&#xD;
             duration of study participation. Should a woman become pregnant or suspect she is&#xD;
             pregnant while participating in this study, she should inform her treating physician&#xD;
             immediately.&#xD;
&#xD;
          -  Breastfeeding should be discontinued if the mother is treated with oxaliplatin.&#xD;
&#xD;
          -  Subjects with chronic hepatitis B or C may be undergoing treatment with α interferon&#xD;
             and/or ribavirin, as long as they meet the other criteria for entry on to this study.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients have prior oxaliplatin or xeloda treatment or undergoing therapy with other&#xD;
             investigational agents.&#xD;
&#xD;
          -  History of allergy to platinum compounds or to antiemetics appropriate for&#xD;
             administration in conjunction with protocol-directed chemotherapy.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active&#xD;
             infection, symptomatic congestive heart failure, or unstable angina pectoris, or&#xD;
             cardiac arrhythmia.&#xD;
&#xD;
          -  HIV-positive patients receiving anti-retroviral therapy (HAART) are excluded from the&#xD;
             study because of possible pharmacokinetic interactions.&#xD;
&#xD;
          -  Patients with a diagnosis of pulmonary fibrosis or a pulmonary interstitial process.&#xD;
&#xD;
          -  Patients unable to swallow capecitabine will be excluded from this study.&#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>Yun Yen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>City of Hope Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <results_first_submitted>January 19, 2017</results_first_submitted>
  <results_first_submitted_qc>January 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 10, 2017</results_first_posted>
  <last_update_submitted>March 16, 2017</last_update_submitted>
  <last_update_submitted_qc>March 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Oxaliplatin and Capecitabine</title>
          <description>21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14&#xD;
Oxaliplatin: Given IV&#xD;
Capecitabine: Given PO</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Oxaliplatin and Capecitabine</title>
          <description>21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14&#xD;
Oxaliplatin: Given IV&#xD;
Capecitabine: Given PO</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
          </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="71" lower_limit="65" upper_limit="74"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </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="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Response Rate</title>
        <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR</description>
        <time_frame>Up to 2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oxaliplatin and Capecitabine</title>
            <description>21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14&#xD;
Oxaliplatin: Given IV&#xD;
Capecitabine: Given PO</description>
          </group>
        </group_list>
        <measure>
          <title>Response Rate</title>
          <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events occurred over a period of 3 months.</time_frame>
      <desc>&quot;Other Adverse Events&quot; include all events that were not severe adverse events regardless of grade or relation to treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Oxaliplatin and Capecitabine</title>
          <description>21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14&#xD;
Oxaliplatin: Given IV&#xD;
Capecitabine: Given PO</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>meddra10.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Colitis, infectious (e.g., Clostridium difficile)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>meddra10.0</default_vocab>
        <default_assessment>Non-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="2" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hemoglobin decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Stomach pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Colitis, infectious (e.g., Clostridium difficile)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </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="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Leukocyte count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Serum albumin decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Serum calcium decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Serum calcium increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Serum magnesium decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Serum phosphate decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Serum potassium decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Serum potassium increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Muscle weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="6" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Taste alteration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pharyngolaryngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Voice alteration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Rash desquamating</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </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>
    <limitations_and_caveats>Due to Sorafenib becoming a first line treatment for HCC, the designed treatment became less competitive. The company Sanofi decided not to continue support. Study was terminated after accrual of 4 of the 32 planned patients.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jeffrey Longmate, Ph.D.</name_or_title>
      <organization>City of Hope</organization>
      <phone>626-256-4673 ext 62478</phone>
      <email>jlongmate@coh.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/NCT03026803
org study id: 05195
nct id: NCT03026803
lead sponsor: 
collaborator: 
has dmc: Yes
This phase II trial is studying how well giving oxaliplatin and capecitabine together works
      in treating patients with liver cancer.
Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to
      stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving these drugs together may kill more tumor cells.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Response Rate
time frame: Up to 2 years
description: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
arm group label: Oxaliplatin and Capecitabine
arm group type: Experimental
description: 21 day cycle with Oxaliplatin 50mg/m2 day 1 and day 8 administered IV, Capecitabine 750 mg/m2 bid p.o. daily from day 1 to day 14
intervention type: Drug
intervention name: Oxaliplatin
description: Given IV
arm group label: Oxaliplatin and Capecitabine
other name: Eloxatin
intervention type: Drug
intervention name: Capecitabine
description: Given PO
arm group label: Oxaliplatin and Capecitabine
other name: Xeloda
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yun Yen, MD
role: Principal Investigator
affiliation: City of Hope Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Liver Neoplasms
mesh term: Carcinoma, Hepatocellular
mesh term: Capecitabine
mesh term: Oxaliplatin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to Sorafenib becoming a first line treatment for HCC, the designed treatment became less competitive. The company Sanofi decided not to continue support. Study was terminated after accrual of 4 of the 32 planned patients.
point of contact: 