<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/NCT01705106</url>
  </required_header>
  <id_info>
    <org_study_id>12-1318</org_study_id>
    <secondary_id>NCI-2012-01704</secondary_id>
    <nct_id>NCT01705106</nct_id>
  </id_info>
  <brief_title>Capecitabine and Celecoxib in Patients With Solid Cancers That Have Been Previously Treated With Standard Therapies</brief_title>
  <official_title>A Drug-drug Interaction Study of Capecitabine and Celecoxib in Patients With Advanced Solid Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial studies capecitabine and celecoxib in treating patients with solid&#xD;
      malignancies that are metastatic or cannot be removed by surgery. Drugs used in chemotherapy,&#xD;
      such as capecitabine, work in different ways to stop the growth of tumor cells, either by&#xD;
      killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor&#xD;
      cells by blocking some of the enzymes needed for cell growth. Giving capecitabine and&#xD;
      celecoxib together may be an effective treatment for solid malignancies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To compare steady state pharmacokinetics (PK) (primarily minimum concentration [Cmin],&#xD;
      maximum concentration [Cmax], and area under the curve [AUC]) of celecoxib on day 7 of&#xD;
      monotherapy versus on day 14 of concomitant administration with capecitabine.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To develop a celecoxib PK drug interaction model using longitudinal data and determine&#xD;
      whether the results are concordant with results from the primary objective.&#xD;
&#xD;
      II. To assess the impact of known cytochrome P450 2C9 (CYP2C9) pharmacogenetic variants with&#xD;
      reduced enzyme activity (CYP2C9*2 and *3) on the between subject variability in celecoxib PK.&#xD;
&#xD;
      III. To assess tumor response by the Response Evaluation Criteria In Solid Tumors (RECIST,&#xD;
      version 1.1) and explore whether there is any correlation between celecoxib PK and response.&#xD;
&#xD;
      IV. To assess toxicity by the Common Terminology Criteria for Adverse Events (CTCAE, version&#xD;
      4.0) and explore whether there is any correlation between celecoxib PK and toxicities related&#xD;
      to either celecoxib or capecitabine.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive celecoxib orally (PO) twice daily (BID) for 7 days (course 0) and then on&#xD;
      days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID&#xD;
      on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease&#xD;
      progression or unacceptable toxicity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated early due to slow accrual.&#xD;
  </why_stopped>
  <start_date type="Actual">August 29, 2012</start_date>
  <completion_date type="Actual">February 10, 2016</completion_date>
  <primary_completion_date type="Actual">February 10, 2016</primary_completion_date>
  <phase>Phase 1</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>AUC of Celecoxib on Combination Therapy (Day 14) and AUC of Celecoxib on Celecoxib Monotherapy(Day 7)</measure>
    <time_frame>Day 7 and 14 post treatment</time_frame>
    <description>These parameters will be estimated for each subject under each treatment condition. The mean ratios (combination therapy/celecoxib monotherapy) will then be estimated together with 90% confidence intervals (CI).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CYP2C9 Genotype</measure>
    <time_frame>one week</time_frame>
    <description>Polymorphisms *2 and *3 will be genotyped and analyzed for their impact on celecoxib AUC using analysis of variance (ANOVA), controlling for gender, age, and other covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response Rate</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Logistic regression analysis will be performed to describe the relationship (if any) between celecoxib AUC and response rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug-related Toxicities</measure>
    <time_frame>Up to six months</time_frame>
    <description>Ordinal logistic regression modeling will be used to explore the relationship between celecoxib AUC and toxicity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Drug Interaction Model</measure>
    <time_frame>4 weeks</time_frame>
    <description>NONMEM software will be used to develop a model describing the drug interaction between capecitabine and celecoxib using PK data collected during the first four weeks of the study.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Unspecified Adult Solid Tumor, Protocol Specific</condition>
  <arm_group>
    <arm_group_label>Treatment (capecitabine, celecoxib)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>capecitabine</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (capecitabine, celecoxib)</arm_group_label>
    <other_name>CAPE</other_name>
    <other_name>Ro 09-1978/000</other_name>
    <other_name>Xeloda</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>celecoxib</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (capecitabine, celecoxib)</arm_group_label>
    <other_name>Celebrex</other_name>
    <other_name>SC-58635</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pharmacological study</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (capecitabine, celecoxib)</arm_group_label>
    <other_name>pharmacological studies</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (capecitabine, celecoxib)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pharmacogenomic studies</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (capecitabine, celecoxib)</arm_group_label>
    <other_name>Pharmacogenomic Study</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed solid tumor that is metastatic or&#xD;
             unresectable and for which standard curative or palliative measures do not exist or&#xD;
             are no longer effective&#xD;
&#xD;
        OR&#xD;
&#xD;
        Histologically or cytologically confirmed solid tumor for which single agent capecitabine&#xD;
        is an appropriate treatment option.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status =&lt; 1&#xD;
&#xD;
          -  Life expectancy &gt; 3 months&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= l500/ul&#xD;
&#xD;
          -  Hemoglobin &gt;= 9g/dL&#xD;
&#xD;
          -  Platelets &gt;= 100,000/ul&#xD;
&#xD;
          -  Creatinine within institutional normal limits or glomerular filtration rate &gt;= 50&#xD;
             mL/min/1.73 m^2 by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI)&#xD;
             equation&#xD;
&#xD;
          -  Total bilirubin &lt; 1.5 x upper limit of normal&#xD;
&#xD;
          -  Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate&#xD;
             transaminase (SGPT) &lt; 2.5 x upper limit of normal for patients without liver&#xD;
             metastases OR SGOT and SGPT &lt; 5 x upper limit of normal for patients with liver&#xD;
             metastases&#xD;
&#xD;
          -  Measurable or non-measurable disease will be allowed&#xD;
&#xD;
          -  Women of child-bearing potential and men must agree to use adequate contraception&#xD;
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for&#xD;
             the duration of study participation, up until 30 days after final study treatment;&#xD;
             should a woman become pregnant or suspect that she is pregnant while participating in&#xD;
             this study, she should inform her treating physician immediately&#xD;
&#xD;
          -  Patients taking substrates of CYP2C9 should be encouraged to switch to alternative&#xD;
             drugs whenever possible, given the potential for drug-drug interactions with the study&#xD;
             drugs&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with capecitabine and/or celecoxib is allowed; however, patients with&#xD;
             a documented history (at the time of enrollment) of &gt;= grade 3 toxicities with&#xD;
             capecitabine or celecoxib are excluded&#xD;
&#xD;
          -  Patients taking any of the following drugs are excluded: inducers or inhibitors of&#xD;
             CYP2C9, warfarin, aspirin, corticosteroids, or non-steroidal anti-inflammatory drugs&#xD;
             (NSAIDs)&#xD;
&#xD;
          -  History of myocardial infarction or stroke within the last 6 months, or history of&#xD;
             uncontrolled cardiovascular or cerebrovascular disease; a 12-lead electrocardiogram&#xD;
             (ECG) will be performed during the screening period&#xD;
&#xD;
          -  History of perforation or bleeding related to peptic ulcer disease&#xD;
&#xD;
          -  History of hypersensitivity or allergy to study drugs, aspirin, sulfonamides, or&#xD;
             NSAIDs&#xD;
&#xD;
          -  Known poor metabolizers of CYP2C9 substrates&#xD;
&#xD;
          -  Known deficiency of dihydropyrimidine dehydrogenase (DPD)&#xD;
&#xD;
          -  Patients who have had chemotherapy, immunotherapy, or investigational anti-cancer&#xD;
             therapy within 4 weeks of starting study drug, or radiotherapy within 14 days of&#xD;
             starting study drug, or those who have not recovered from adverse events due to agents&#xD;
             administered more than 4 weeks earlier&#xD;
&#xD;
          -  Patients may not be receiving any other investigational agents or any concomitant&#xD;
             antineoplastic therapy, with the exception of androgen ablating agents (for patients&#xD;
             with prior prostate cancer)&#xD;
&#xD;
          -  Serious underlying medical or psychiatric illnesses that would, in the opinion of the&#xD;
             treating physician, substantially increase the risk for complications related to&#xD;
             treatment; similarly, any unstable medical condition that in the opinion of the&#xD;
             treating physician or study investigators, would interfere with determination of the&#xD;
             study objectives&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Major surgery within 4 weeks&#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>Manish R. Sharma, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago Comprehensive Cancer Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637-1470</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <results_first_submitted>February 14, 2018</results_first_submitted>
  <results_first_submitted_qc>April 30, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">May 30, 2018</results_first_posted>
  <last_update_submitted>April 30, 2018</last_update_submitted>
  <last_update_submitted_qc>April 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celecoxib</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment (Capecitabine, Celecoxib)</title>
          <description>Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.&#xD;
capecitabine: Given PO&#xD;
celecoxib: Given PO&#xD;
pharmacological study: Correlative studies&#xD;
laboratory biomarker analysis: Correlative studies&#xD;
pharmacogenomic studies: Correlative studies</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment (Capecitabine, Celecoxib)</title>
          <description>Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.&#xD;
capecitabine: Given PO&#xD;
celecoxib: Given PO&#xD;
pharmacological study: Correlative studies&#xD;
laboratory biomarker analysis: Correlative studies&#xD;
pharmacogenomic studies: Correlative studies</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
          </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="57.5" lower_limit="52" upper_limit="67"/>
                  </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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>AUC of Celecoxib on Combination Therapy (Day 14) and AUC of Celecoxib on Celecoxib Monotherapy(Day 7)</title>
        <description>These parameters will be estimated for each subject under each treatment condition. The mean ratios (combination therapy/celecoxib monotherapy) will then be estimated together with 90% confidence intervals (CI).</description>
        <time_frame>Day 7 and 14 post treatment</time_frame>
        <population>The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Capecitabine, Celecoxib)</title>
            <description>Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.&#xD;
capecitabine: Given PO&#xD;
celecoxib: Given PO&#xD;
pharmacological study: Correlative studies&#xD;
laboratory biomarker analysis: Correlative studies&#xD;
pharmacogenomic studies: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>AUC of Celecoxib on Combination Therapy (Day 14) and AUC of Celecoxib on Celecoxib Monotherapy(Day 7)</title>
          <description>These parameters will be estimated for each subject under each treatment condition. The mean ratios (combination therapy/celecoxib monotherapy) will then be estimated together with 90% confidence intervals (CI).</description>
          <population>The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CYP2C9 Genotype</title>
        <description>Polymorphisms *2 and *3 will be genotyped and analyzed for their impact on celecoxib AUC using analysis of variance (ANOVA), controlling for gender, age, and other covariates.</description>
        <time_frame>one week</time_frame>
        <population>The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Capecitabine, Celecoxib)</title>
            <description>Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.&#xD;
capecitabine: Given PO&#xD;
celecoxib: Given PO&#xD;
pharmacological study: Correlative studies&#xD;
laboratory biomarker analysis: Correlative studies&#xD;
pharmacogenomic studies: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>CYP2C9 Genotype</title>
          <description>Polymorphisms *2 and *3 will be genotyped and analyzed for their impact on celecoxib AUC using analysis of variance (ANOVA), controlling for gender, age, and other covariates.</description>
          <population>The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Response Rate</title>
        <description>Logistic regression analysis will be performed to describe the relationship (if any) between celecoxib AUC and response rate.</description>
        <time_frame>Up to 2 years</time_frame>
        <population>The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Capecitabine, Celecoxib)</title>
            <description>Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.&#xD;
capecitabine: Given PO&#xD;
celecoxib: Given PO&#xD;
pharmacological study: Correlative studies&#xD;
laboratory biomarker analysis: Correlative studies&#xD;
pharmacogenomic studies: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Response Rate</title>
          <description>Logistic regression analysis will be performed to describe the relationship (if any) between celecoxib AUC and response rate.</description>
          <population>The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Drug-related Toxicities</title>
        <description>Ordinal logistic regression modeling will be used to explore the relationship between celecoxib AUC and toxicity.</description>
        <time_frame>Up to six months</time_frame>
        <population>The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Capecitabine, Celecoxib)</title>
            <description>Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.&#xD;
capecitabine: Given PO&#xD;
celecoxib: Given PO&#xD;
pharmacological study: Correlative studies&#xD;
laboratory biomarker analysis: Correlative studies&#xD;
pharmacogenomic studies: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Drug-related Toxicities</title>
          <description>Ordinal logistic regression modeling will be used to explore the relationship between celecoxib AUC and toxicity.</description>
          <population>The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Drug Interaction Model</title>
        <description>NONMEM software will be used to develop a model describing the drug interaction between capecitabine and celecoxib using PK data collected during the first four weeks of the study.</description>
        <time_frame>4 weeks</time_frame>
        <population>The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Capecitabine, Celecoxib)</title>
            <description>Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.&#xD;
capecitabine: Given PO&#xD;
celecoxib: Given PO&#xD;
pharmacological study: Correlative studies&#xD;
laboratory biomarker analysis: Correlative studies&#xD;
pharmacogenomic studies: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>PK Drug Interaction Model</title>
          <description>NONMEM software will be used to develop a model describing the drug interaction between capecitabine and celecoxib using PK data collected during the first four weeks of the study.</description>
          <population>The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Patients were followed for 30 days post treatment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment (Capecitabine, Celecoxib)</title>
          <description>Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.&#xD;
capecitabine: Given PO&#xD;
celecoxib: Given PO&#xD;
pharmacological study: Correlative studies&#xD;
laboratory biomarker analysis: Correlative studies&#xD;
pharmacogenomic studies: Correlative studies</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>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="9" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders - Other (Pneumonia)</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Palmar-plantar erythrodysesthesia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="20" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract, right eye</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Anal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other (Excessive saliva)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Lip pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Mucositis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Oral dysesthesia, intermittent</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Proctitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Stomach pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pain, intermittent left sided pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pain, left shoulder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pain, Right shoulder pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Eye infection, left eye staph infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Infections and infestations - Other (Black thrush)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Infections and infestations - Other (Oral thrush)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Infections and infestations - Other (Right hand laceration)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Lip infection, herpes skin lesion upper lip</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nail infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Papulopustular rash, hands</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Injury, poisoning and procedural complications - Other (Pulled posterior left chest wall muscle)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood bilirubin increased, intermittent (Gilbert's syndrome)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </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" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Flank pain, right</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Headache, intermittent</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Paresthesia, right arm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Paresthesia, Right eye over cheek</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Tremor, hands</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Psychiatric disorders - Other (rage/altered mental status)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Postnasal drip, intermittent</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders - Other (Pneumonia)</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bullous dermatitis (on heels from treadmill)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dry skin, palms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysesthesia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rash, back and hands</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rash, forearms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rash, scrotum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other (hypochromic lesions chest/nipples)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other (Night sweats)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>&quot;Skin and subcutaneous tissue disorders - Other (Skin lesion right shoulder)&quot;</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Skin hyperpigmentation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Thromboembolic event (pulmonary embolism)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flashes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypotension, orthostatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Manish R. Sharma, MD</name_or_title>
      <organization>University of Chicago</organization>
      <phone>773-834-0312</phone>
      <email>msharma@bsd.uchicago.edu</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/NCT01705106
org study id: 12-1318
secondary id: NCI-2012-01704
nct id: NCT01705106
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This clinical trial studies capecitabine and celecoxib in treating patients with solid
      malignancies that are metastatic or cannot be removed by surgery. Drugs used in chemotherapy,
      such as capecitabine, work in different ways to stop the growth of tumor cells, either by
      killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor
      cells by blocking some of the enzymes needed for cell growth. Giving capecitabine and
      celecoxib together may be an effective treatment for solid malignancies.
PRIMARY OBJECTIVES:

      I. To compare steady state pharmacokinetics (PK) (primarily minimum concentration [Cmin],
      maximum concentration [Cmax], and area under the curve [AUC]) of celecoxib on day 7 of
      monotherapy versus on day 14 of concomitant administration with capecitabine.

      SECONDARY OBJECTIVES:

      I. To develop a celecoxib PK drug interaction model using longitudinal data and determine
      whether the results are concordant with results from the primary objective.

      II. To assess the impact of known cytochrome P450 2C9 (CYP2C9) pharmacogenetic variants with
      reduced enzyme activity (CYP2C9*2 and *3) on the between subject variability in celecoxib PK.

      III. To assess tumor response by the Response Evaluation Criteria In Solid Tumors (RECIST,
      version 1.1) and explore whether there is any correlation between celecoxib PK and response.

      IV. To assess toxicity by the Common Terminology Criteria for Adverse Events (CTCAE, version
      4.0) and explore whether there is any correlation between celecoxib PK and toxicities related
      to either celecoxib or capecitabine.

      OUTLINE:

      Patients receive celecoxib orally (PO) twice daily (BID) for 7 days (course 0) and then on
      days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID
      on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease
      progression or unacceptable toxicity.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC of Celecoxib on Combination Therapy (Day 14) and AUC of Celecoxib on Celecoxib Monotherapy(Day 7)
time frame: Day 7 and 14 post treatment
description: These parameters will be estimated for each subject under each treatment condition. The mean ratios (combination therapy/celecoxib monotherapy) will then be estimated together with 90% confidence intervals (CI).
measure: CYP2C9 Genotype
time frame: one week
description: Polymorphisms *2 and *3 will be genotyped and analyzed for their impact on celecoxib AUC using analysis of variance (ANOVA), controlling for gender, age, and other covariates.
measure: Response Rate
time frame: Up to 2 years
description: Logistic regression analysis will be performed to describe the relationship (if any) between celecoxib AUC and response rate.
measure: Drug-related Toxicities
time frame: Up to six months
description: Ordinal logistic regression modeling will be used to explore the relationship between celecoxib AUC and toxicity.
measure: PK Drug Interaction Model
time frame: 4 weeks
description: NONMEM software will be used to develop a model describing the drug interaction between capecitabine and celecoxib using PK data collected during the first four weeks of the study.
arm group label: Treatment (capecitabine, celecoxib)
arm group type: Experimental
description: Patients receive celecoxib PO BID for 7 days (course 0) and then on days 1-21 of course 1 and all subsequent courses. Patients also receive capecitabine PO BID on days 1-14 beginning in course 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: capecitabine
description: Given PO
arm group label: Treatment (capecitabine, celecoxib)
other name: CAPE
other name: Ro 09-1978/000
other name: Xeloda
intervention type: Drug
intervention name: celecoxib
description: Given PO
arm group label: Treatment (capecitabine, celecoxib)
other name: Celebrex
other name: SC-58635
intervention type: Other
intervention name: pharmacological study
description: Correlative studies
arm group label: Treatment (capecitabine, celecoxib)
other name: pharmacological studies
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Treatment (capecitabine, celecoxib)
intervention type: Other
intervention name: pharmacogenomic studies
description: Correlative studies
arm group label: Treatment (capecitabine, celecoxib)
other name: Pharmacogenomic Study
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Manish R. Sharma, M.D.
role: Principal Investigator
affiliation: University of Chicago Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Celecoxib
mesh term: Capecitabine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 