<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/NCT01693523</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0587</org_study_id>
    <secondary_id>1R21CA158902-01A1</secondary_id>
    <secondary_id>NCI-2012-02063</secondary_id>
    <nct_id>NCT01693523</nct_id>
  </id_info>
  <brief_title>Minocycline Study in Pancreatic Cancer Patients</brief_title>
  <official_title>A Randomized, Placebo Controlled-Double Blind Study of Minocycline for Reducing the Symptom Burden for Pancreatic Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this clinical research study is to learn if minocycline can reduce the side&#xD;
      effects of chemotherapy in patients with pancreatic cancer. In this study, minocycline will&#xD;
      be compared to a placebo.&#xD;
&#xD;
      Minocycline is an antibiotic that may help to reduce side effects of chemotherapy.&#xD;
&#xD;
      A placebo is not a drug. It looks like the study drug, but it is not designed to treat any&#xD;
      disease or illness. It is designed to be compared with a study drug to learn if the study&#xD;
      drug has any real effect.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Groups:&#xD;
&#xD;
      If you agree to take part in this study, you will be randomly assigned (as in the flip of a&#xD;
      coin) to 1 of 2 groups. You will have an equal chance of being in either group:&#xD;
&#xD;
        -  If you are in Group 1, you will take minocycline.&#xD;
&#xD;
        -  If you are in Group 2, you will take a placebo.&#xD;
&#xD;
      Neither you nor the study staff will know if you are receiving the study drug or the placebo.&#xD;
      However, if needed for your safety, the study staff will be able to find out what you are&#xD;
      receiving.&#xD;
&#xD;
      Study Drug Administration:&#xD;
&#xD;
      Each study cycle is about 2 weeks.&#xD;
&#xD;
      You will begin taking the study drug/placebo on, or within 2 days of, Day 1 of the first&#xD;
      chemotherapy cycle after you are enrolled on the study. You will take the study drug/placebo&#xD;
      capsule by mouth, every day for up to 4 cycles (up to 8 weeks, if there are no treatment&#xD;
      delays).&#xD;
&#xD;
      It is possible that your chemotherapy start may be delayed if it takes additional time for&#xD;
      your central venous catheter (CVC) to be placed. A CVC is a sterile flexible tube that will&#xD;
      be placed into a large vein while you are under local anesthesia. If this happens, you may&#xD;
      choose to start taking the study drug/placebo up to 2 weeks before you start chemotherapy,&#xD;
      instead of waiting to start taking it on the same day your chemotherapy begins. You can&#xD;
      discuss these options with the study doctor.&#xD;
&#xD;
      You should take the study drug/placebo dissolved in a full glass (8 ounces) of water. You may&#xD;
      take it with or without food, but if it causes an upset stomach, you should take it with&#xD;
      food.&#xD;
&#xD;
      If you have trouble swallowing the dose of study drug/placebo, you can open the capsule right&#xD;
      before you take it. You should not lie down for at least 30 minutes after taking the study&#xD;
      drug/placebo to reduce the risk of side effects.&#xD;
&#xD;
      You must bring the study drug/placebo container (along with any remaining drug/placebo) to&#xD;
      every study visit.&#xD;
&#xD;
      Study Visits:&#xD;
&#xD;
      Before you start your treatment with the study drug/placebo:&#xD;
&#xD;
        -  If you can become pregnant, blood (about 2 teaspoons) will be drawn for a pregnancy&#xD;
           test. If the pregnancy test is positive, it will be repeated after 48 hours to make sure&#xD;
           you are pregnant. Sometimes, cancer can cause a &quot;false positive&quot; on a pregnancy test.&#xD;
&#xD;
        -  You will complete 2 questionnaires about pain and other symptoms, and your quality of&#xD;
           life. It should take about 5-8 minutes to complete all of the questionnaires.&#xD;
&#xD;
        -  If possible, blood (about 2 tablespoons) will be drawn to test for markers of&#xD;
           inflammation. Markers of inflammation are found in the blood and may be related to your&#xD;
           symptom development.&#xD;
&#xD;
        -  Your demographic information, such as your marital status, job status, education, and&#xD;
           race will be recorded.&#xD;
&#xD;
      Before you start your chemotherapy treatment:&#xD;
&#xD;
      °If possible, blood (about 2 teaspoons) may be drawn to test for markers of inflammation,&#xD;
      only if you started treatment with the study drug/placebo while you waited for your CVC to be&#xD;
      placed for chemotherapy. If you choose to wait to start the study drug/placebo until&#xD;
      chemotherapy begins, this blood sample will not be drawn.&#xD;
&#xD;
      During treatment with the study drug/placebo:&#xD;
&#xD;
        -  You will complete the symptom questionnaire 2 times each week during the first cycle and&#xD;
           1 time each week during any remaining cycles. The symptom questionnaire asks about any&#xD;
           symptoms you may be having and how they may be affecting your daily activities. You will&#xD;
           also complete the quality of life questionnaire. The questionnaires should take about&#xD;
           3-5 minutes to complete each time.&#xD;
&#xD;
        -  You will complete the questionnaires in paper-and-pencil format or on an electronic&#xD;
           tablet PC if you are in the clinic. When you are away from the clinic you will complete&#xD;
           the questionnaires on the telephone or on your computer.&#xD;
&#xD;
        -  If possible, during your clinic visits at the start of cycle 2, 3, and 4 (if&#xD;
           applicable), blood (about 2 tablespoons) may be drawn to test for markers of&#xD;
           inflammation.&#xD;
&#xD;
      At the end of study drug/placebo treatment:&#xD;
&#xD;
      When you have finished taking the study drug/placebo, the study staff will contact you to&#xD;
      complete a questionnaire asking you about your opinions of the study drug/placebo. This&#xD;
      questionnaire will take about 3-5 minutes to complete.&#xD;
&#xD;
      Length of Study Participation:&#xD;
&#xD;
      You will be on study for up to 8 weeks, if there is no delay in starting your chemotherapy&#xD;
      cycles. You will take the study drug/placebo for up to 8 weeks. You will be taken off study&#xD;
      early if the disease gets worse, you have intolerable side effects, if you are unable to&#xD;
      follow study directions, or the study doctor thinks it is in your best interest.&#xD;
&#xD;
      End-of-Study Visit:&#xD;
&#xD;
      At the end of the last study cycle after you complete the symptom treatment, you will&#xD;
      complete questionnaires about pain and other symptoms and your quality of life. It should&#xD;
      take about 3-5 minutes to complete the questionnaires. If possible, blood (about 2&#xD;
      tablespoons) may be drawn to test for markers of inflammation.&#xD;
&#xD;
      Follow-Up:&#xD;
&#xD;
      The study staff will call you 30 days after you finish taking the study drug/placebo to ask&#xD;
      about any side effects you may be having. This call should last about 5 minutes.&#xD;
&#xD;
      This is an investigational study. Minocycline is FDA approved and commercially available for&#xD;
      the treatment of bacterial infection. Using minocycline to try to reduce the side effects of&#xD;
      chemotherapy in patients with pancreatic cancer is investigational.&#xD;
&#xD;
      Up to 76 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 type="Actual">January 28, 2013</start_date>
  <completion_date type="Actual">September 19, 2018</completion_date>
  <primary_completion_date type="Actual">September 19, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average Area Under the Curve (AUC) of Apriori Selected MDASI Symptoms</measure>
    <time_frame>AUC from baseline to 2 weeks</time_frame>
    <description>Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference using the MD Anderson Symptom Inventory (MDASI). It is a measure of symptom burden, which includes symptom severity and how they interfere with daily functioning. For this study, the sub scale is the average of the 5 pre-selected items namely fatigue, pain, disturbed sleep, lack of appetite and drowsiness. This subscale ranges from 0 to 10. The primary outcome is the average of the 70-day area (10 week study) under the curve for the sub scale. AUC ranges from 0 (0*70) to 700 (10*70). To put this into perspective, the average AUC for the placebo group of 200.8 can also be thought of as 2.87 (200.8/70) on a 0 to 10 scale over the 70 day study period. Lower values represent better outcome. Higher values represent worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relationship Between Dynamic Changes in Inflammation Biomarkers and Symptom Outcomes, Controlling for the Grouping Variables (Tumor Markers, Weight Loss), Evidence of Infection, ECOG PS, Age and Gender Examined</measure>
    <time_frame>3 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Minocycline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Minocycline</intervention_name>
    <description>100 mg by mouth two times a day (200 mg/day).</description>
    <arm_group_label>Minocycline</arm_group_label>
    <other_name>Dynacin</other_name>
    <other_name>Minocin</other_name>
    <other_name>Minocin PAC</other_name>
    <other_name>Myrac</other_name>
    <other_name>Solodyn</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo capsules by mouth twice a day.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Sugar pill</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.</description>
    <arm_group_label>Minocycline</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Surveys</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Minocycline Trial only: Patients with a pathological or clinical diagnosis of&#xD;
             pancreatic cancer and beginning or continuing FOLFIRINOX or gemcitabine-based&#xD;
             chemotherapy.&#xD;
&#xD;
          2. Observational Arm only: Patients with a pathological or clinical diagnosis of&#xD;
             pancreatic cancer and beginning or continuing FOLFIRINOX chemotherapy.&#xD;
&#xD;
          3. Patients &gt; 18 years old.&#xD;
&#xD;
          4. Minocycline Trial only: Patients with ECOG PS = 0-2.&#xD;
&#xD;
          5. Patients who speak English or Spanish (due to MDASI language options, we are only&#xD;
             accruing English-speaking or Spanish-speaking patients to the protocol).&#xD;
&#xD;
          6. Patients willing and able to review, understand, and provide written consent before&#xD;
             starting therapy.&#xD;
&#xD;
          7. Minocycline Trial only: Patients with adequate renal function according to MD Anderson&#xD;
             testing standards (screening cut off for serum creatinine &lt; 2 times the upper limit of&#xD;
             normal).&#xD;
&#xD;
          8. Minocycline Trial only: Patients with adequate hepatic function according to MD&#xD;
             Anderson testing standards (screening results for total bilirubin must be &lt; 2 times&#xD;
             the upper limit of normal; screening results for alanine aminotransferase (ALT) must&#xD;
             be &lt; 3 times the upper limit of normal; screening results for aspartate&#xD;
             aminotransferase (AST), if available, must be &lt; 3 times the upper limit of normal).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Minocycline Trial only: Patients who are taking medication or have conditions that&#xD;
             potentially preclude use of minocycline, as determined by the treating physician.&#xD;
&#xD;
          2. Patients who are enrolled in other symptom management clinical trials.&#xD;
&#xD;
          3. Minocycline Trial only: Patients who currently have bile duct obstruction or&#xD;
             cholelithiasis.&#xD;
&#xD;
          4. Minocycline Trial only: Patients with hypersensitivity to any tetracyclines.&#xD;
&#xD;
          5. Minocycline Trial only: Patients who are pregnant. Pregnancy will be confirmed by&#xD;
             negative urine test; patients with a positive urine test will be retested for doubling&#xD;
             of HCG 48 hours after the first test, because of beta-HCG's role as a tumor marker.&#xD;
             Patients without such a rise will be eligible for the study and will be enrolled at&#xD;
             the investigator's discretion.&#xD;
&#xD;
          6. Minocycline Trial only: Patients who are under treatment of warfarin with INR &gt; 1.5.&#xD;
&#xD;
          7. Patients who, in the judgment of the investigator, may be unable to participate in the&#xD;
             required study procedures.&#xD;
&#xD;
          8. Minocycline Trial only: Patients who have had prior treatment for pancreatic cancer&#xD;
             within the past six months may be excluded at the discretion of the investigator.&#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>David Fogelman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shelley Wang, MD,MPH</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>February 2020</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <results_first_submitted>January 29, 2020</results_first_submitted>
  <results_first_submitted_qc>February 7, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 19, 2020</results_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreatic Cancer</keyword>
  <keyword>Pancreatic adenocarcinoma</keyword>
  <keyword>Locally advanced</keyword>
  <keyword>Metastatic disease</keyword>
  <keyword>Symptom reduction</keyword>
  <keyword>Minocycline</keyword>
  <keyword>Dynacin</keyword>
  <keyword>Minocin</keyword>
  <keyword>Minocin PAC</keyword>
  <keyword>Myrac</keyword>
  <keyword>Solodyn</keyword>
  <keyword>Placebo</keyword>
  <keyword>Sugar Pill</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Surveys</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Minocycline</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 18, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT01693523/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment period: February 20, 2013 to October, 20 2015. All recruitment done at the University of Texas MD Anderson Cancer</recruitment_details>
      <pre_assignment_details>Of the 80 participants enrolled 1 participant were excluded from the study before assignment to groups.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Minocycline</title>
          <description>Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.&#xD;
Minocycline: 100 mg by mouth two times a day (200 mg/day).&#xD;
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.&#xD;
Placebo: Matching placebo capsules by mouth twice a day.&#xD;
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.</description>
        </group>
        <group group_id="P3">
          <title>Observational</title>
          <description>No Intervention</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of compliance study medication</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Chemotherapy was held</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Minocycline</title>
          <description>Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.&#xD;
Minocycline: 100 mg by mouth two times a day (200 mg/day).&#xD;
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.&#xD;
Placebo: Matching placebo capsules by mouth twice a day.&#xD;
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.</description>
        </group>
        <group group_id="B3">
          <title>Observational</title>
          <description>Non Intervention</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="23"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="35"/>
            <count group_id="B4" value="79"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="30"/>
                  </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="11"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </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="23"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Area Under the Curve (AUC) of Apriori Selected MDASI Symptoms</title>
        <description>Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference using the MD Anderson Symptom Inventory (MDASI). It is a measure of symptom burden, which includes symptom severity and how they interfere with daily functioning. For this study, the sub scale is the average of the 5 pre-selected items namely fatigue, pain, disturbed sleep, lack of appetite and drowsiness. This subscale ranges from 0 to 10. The primary outcome is the average of the 70-day area (10 week study) under the curve for the sub scale. AUC ranges from 0 (0*70) to 700 (10*70). To put this into perspective, the average AUC for the placebo group of 200.8 can also be thought of as 2.87 (200.8/70) on a 0 to 10 scale over the 70 day study period. Lower values represent better outcome. Higher values represent worse outcome.</description>
        <time_frame>AUC from baseline to 2 weeks</time_frame>
        <population>Of the 44 randomized patients, 30 (68% were evaluable for the primary efficacy analysis).</population>
        <group_list>
          <group group_id="O1">
            <title>Minocycline</title>
            <description>Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.&#xD;
Minocycline: 100 mg by mouth two times a day (200 mg/day).&#xD;
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.&#xD;
Placebo: Matching placebo capsules by mouth twice a day.&#xD;
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.</description>
          </group>
          <group group_id="O3">
            <title>Observational</title>
            <description>No Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Average Area Under the Curve (AUC) of Apriori Selected MDASI Symptoms</title>
          <description>Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference using the MD Anderson Symptom Inventory (MDASI). It is a measure of symptom burden, which includes symptom severity and how they interfere with daily functioning. For this study, the sub scale is the average of the 5 pre-selected items namely fatigue, pain, disturbed sleep, lack of appetite and drowsiness. This subscale ranges from 0 to 10. The primary outcome is the average of the 70-day area (10 week study) under the curve for the sub scale. AUC ranges from 0 (0*70) to 700 (10*70). To put this into perspective, the average AUC for the placebo group of 200.8 can also be thought of as 2.87 (200.8/70) on a 0 to 10 scale over the 70 day study period. Lower values represent better outcome. Higher values represent worse outcome.</description>
          <population>Of the 44 randomized patients, 30 (68% were evaluable for the primary efficacy analysis).</population>
          <units>Units on a scale *days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.5" spread="31.4"/>
                    <measurement group_id="O2" value="30.6" spread="19.9"/>
                    <measurement group_id="O3" value="36.2" spread="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relationship Between Dynamic Changes in Inflammation Biomarkers and Symptom Outcomes, Controlling for the Grouping Variables (Tumor Markers, Weight Loss), Evidence of Infection, ECOG PS, Age and Gender Examined</title>
        <time_frame>3 weeks</time_frame>
        <population>The blood sample collection was an optional procedure for the participants data were not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Minocycline</title>
            <description>Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.&#xD;
Minocycline: 100 mg by mouth two times a day (200 mg/day).&#xD;
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.&#xD;
Placebo: Matching placebo capsules by mouth twice a day.&#xD;
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.</description>
          </group>
          <group group_id="O3">
            <title>Observational</title>
            <description>No Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Relationship Between Dynamic Changes in Inflammation Biomarkers and Symptom Outcomes, Controlling for the Grouping Variables (Tumor Markers, Weight Loss), Evidence of Infection, ECOG PS, Age and Gender Examined</title>
          <population>The blood sample collection was an optional procedure for the participants data were not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of study and the study completion, an average of 2 years,8 months</time_frame>
      <desc>Adverse Events were not monitored/assessed for participants in the &quot;Observational&quot; Arm/Group.</desc>
      <group_list>
        <group group_id="E1">
          <title>Minocycline</title>
          <description>Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.&#xD;
Minocycline: 100 mg by mouth two times a day (200 mg/day).&#xD;
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.&#xD;
Placebo: Matching placebo capsules by mouth twice a day.&#xD;
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.</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="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sudden cardiopulmonare</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</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="3" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Splenic infiltarion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title vocab="CTCV4">Hypokalemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </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. David Fogelman/ Associate Professor, GI Medical Oncology</name_or_title>
      <organization>UT MD Anderson Cancer Center</organization>
      <phone>832-710-7754</phone>
      <email>dfogelman@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/NCT01693523
org study id: 2012-0587
secondary id: 1R21CA158902-01A1
secondary id: NCI-2012-02063
nct id: NCT01693523
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The goal of this clinical research study is to learn if minocycline can reduce the side
      effects of chemotherapy in patients with pancreatic cancer. In this study, minocycline will
      be compared to a placebo.

      Minocycline is an antibiotic that may help to reduce side effects of chemotherapy.

      A placebo is not a drug. It looks like the study drug, but it is not designed to treat any
      disease or illness. It is designed to be compared with a study drug to learn if the study
      drug has any real effect.
Study Groups:

      If you agree to take part in this study, you will be randomly assigned (as in the flip of a
      coin) to 1 of 2 groups. You will have an equal chance of being in either group:

        -  If you are in Group 1, you will take minocycline.

        -  If you are in Group 2, you will take a placebo.

      Neither you nor the study staff will know if you are receiving the study drug or the placebo.
      However, if needed for your safety, the study staff will be able to find out what you are
      receiving.

      Study Drug Administration:

      Each study cycle is about 2 weeks.

      You will begin taking the study drug/placebo on, or within 2 days of, Day 1 of the first
      chemotherapy cycle after you are enrolled on the study. You will take the study drug/placebo
      capsule by mouth, every day for up to 4 cycles (up to 8 weeks, if there are no treatment
      delays).

      It is possible that your chemotherapy start may be delayed if it takes additional time for
      your central venous catheter (CVC) to be placed. A CVC is a sterile flexible tube that will
      be placed into a large vein while you are under local anesthesia. If this happens, you may
      choose to start taking the study drug/placebo up to 2 weeks before you start chemotherapy,
      instead of waiting to start taking it on the same day your chemotherapy begins. You can
      discuss these options with the study doctor.

      You should take the study drug/placebo dissolved in a full glass (8 ounces) of water. You may
      take it with or without food, but if it causes an upset stomach, you should take it with
      food.

      If you have trouble swallowing the dose of study drug/placebo, you can open the capsule right
      before you take it. You should not lie down for at least 30 minutes after taking the study
      drug/placebo to reduce the risk of side effects.

      You must bring the study drug/placebo container (along with any remaining drug/placebo) to
      every study visit.

      Study Visits:

      Before you start your treatment with the study drug/placebo:

        -  If you can become pregnant, blood (about 2 teaspoons) will be drawn for a pregnancy
           test. If the pregnancy test is positive, it will be repeated after 48 hours to make sure
           you are pregnant. Sometimes, cancer can cause a "false positive" on a pregnancy test.

        -  You will complete 2 questionnaires about pain and other symptoms, and your quality of
           life. It should take about 5-8 minutes to complete all of the questionnaires.

        -  If possible, blood (about 2 tablespoons) will be drawn to test for markers of
           inflammation. Markers of inflammation are found in the blood and may be related to your
           symptom development.

        -  Your demographic information, such as your marital status, job status, education, and
           race will be recorded.

      Before you start your chemotherapy treatment:

      °If possible, blood (about 2 teaspoons) may be drawn to test for markers of inflammation,
      only if you started treatment with the study drug/placebo while you waited for your CVC to be
      placed for chemotherapy. If you choose to wait to start the study drug/placebo until
      chemotherapy begins, this blood sample will not be drawn.

      During treatment with the study drug/placebo:

        -  You will complete the symptom questionnaire 2 times each week during the first cycle and
           1 time each week during any remaining cycles. The symptom questionnaire asks about any
           symptoms you may be having and how they may be affecting your daily activities. You will
           also complete the quality of life questionnaire. The questionnaires should take about
           3-5 minutes to complete each time.

        -  You will complete the questionnaires in paper-and-pencil format or on an electronic
           tablet PC if you are in the clinic. When you are away from the clinic you will complete
           the questionnaires on the telephone or on your computer.

        -  If possible, during your clinic visits at the start of cycle 2, 3, and 4 (if
           applicable), blood (about 2 tablespoons) may be drawn to test for markers of
           inflammation.

      At the end of study drug/placebo treatment:

      When you have finished taking the study drug/placebo, the study staff will contact you to
      complete a questionnaire asking you about your opinions of the study drug/placebo. This
      questionnaire will take about 3-5 minutes to complete.

      Length of Study Participation:

      You will be on study for up to 8 weeks, if there is no delay in starting your chemotherapy
      cycles. You will take the study drug/placebo for up to 8 weeks. You will be taken off study
      early if the disease gets worse, you have intolerable side effects, if you are unable to
      follow study directions, or the study doctor thinks it is in your best interest.

      End-of-Study Visit:

      At the end of the last study cycle after you complete the symptom treatment, you will
      complete questionnaires about pain and other symptoms and your quality of life. It should
      take about 3-5 minutes to complete the questionnaires. If possible, blood (about 2
      tablespoons) may be drawn to test for markers of inflammation.

      Follow-Up:

      The study staff will call you 30 days after you finish taking the study drug/placebo to ask
      about any side effects you may be having. This call should last about 5 minutes.

      This is an investigational study. Minocycline is FDA approved and commercially available for
      the treatment of bacterial infection. Using minocycline to try to reduce the side effects of
      chemotherapy in patients with pancreatic cancer is investigational.

      Up to 76 patients will take part in this study. All will be enrolled at MD Anderson.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Average Area Under the Curve (AUC) of Apriori Selected MDASI Symptoms
time frame: AUC from baseline to 2 weeks
description: Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference using the MD Anderson Symptom Inventory (MDASI). It is a measure of symptom burden, which includes symptom severity and how they interfere with daily functioning. For this study, the sub scale is the average of the 5 pre-selected items namely fatigue, pain, disturbed sleep, lack of appetite and drowsiness. This subscale ranges from 0 to 10. The primary outcome is the average of the 70-day area (10 week study) under the curve for the sub scale. AUC ranges from 0 (0*70) to 700 (10*70). To put this into perspective, the average AUC for the placebo group of 200.8 can also be thought of as 2.87 (200.8/70) on a 0 to 10 scale over the 70 day study period. Lower values represent better outcome. Higher values represent worse outcome.
measure: Relationship Between Dynamic Changes in Inflammation Biomarkers and Symptom Outcomes, Controlling for the Grouping Variables (Tumor Markers, Weight Loss), Evidence of Infection, ECOG PS, Age and Gender Examined
time frame: 3 weeks
arm group label: Minocycline
arm group type: Experimental
description: Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
intervention type: Drug
intervention name: Minocycline
description: 100 mg by mouth two times a day (200 mg/day).
arm group label: Minocycline
other name: Dynacin
other name: Minocin
other name: Minocin PAC
other name: Myrac
other name: Solodyn
intervention type: Other
intervention name: Placebo
description: Matching placebo capsules by mouth twice a day.
arm group label: Placebo
other name: Sugar pill
intervention type: Behavioral
intervention name: Questionnaires
description: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
arm group label: Minocycline
arm group label: Placebo
other name: Surveys
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Fogelman, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
last name: Shelley Wang, MD,MPH
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: Pancreatic Neoplasms
mesh term: Minocycline
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 