<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/NCT01715233</url>
  </required_header>
  <id_info>
    <org_study_id>J1248</org_study_id>
    <secondary_id>NA_00073720</secondary_id>
    <nct_id>NCT01715233</nct_id>
  </id_info>
  <brief_title>Phase II Study Using CHFR Methylation Status in Patients With Metastatic Esophageal, Gastroesophageal, Gastric Cancer.</brief_title>
  <official_title>A Phase II Study Investigating CHFR Methylation Status As A Biomarker For Taxane Sensitivity Using Modified Docetaxel, Cisplatin and 5 Fluorouracil In Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To estimate and compare the response rates in patients treated with mDCF based on methylation&#xD;
      status of CHFR.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To estimate and compare the response rates in patients treated with mDCF based on methylation&#xD;
      status of CHFR. The overall response rates in the un-methylated and methylated patient groups&#xD;
      will be reported with a exact 95% binomial confidence interval. A chi-square test will be&#xD;
      used for comparison.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2012</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Response</measure>
    <time_frame>4 months</time_frame>
    <description>Number of participants treated with mDCF with progressive disease (PD), stable disease (SD), partial response (PR), non-complete response and non-progressive disease (non-CR/non-PD), and partial response with progressive disease clinically (PR/PD) as defined by RECIST criteria. Response is compared based on CHFR-methylation status.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CHFR Methylation Status</measure>
    <time_frame>Baseline</time_frame>
    <description>Number of participants with advanced esophagogastric cancer that are CHFR-methylated or unmethylated at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>2 Years</time_frame>
    <description>Number of participants alive at 2 years.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Metastatic Esophageal Cancer</condition>
  <condition>Gastroesophageal Cancer</condition>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Metastatic Esophageal, Gastroesophageal &amp; Gastric Cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>Modified Docetaxel 40mg/m2 on Day 1</description>
    <arm_group_label>Metastatic Esophageal, Gastroesophageal &amp; Gastric Cancer</arm_group_label>
    <other_name>Modified DCF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leucovorin</intervention_name>
    <description>Leucovorin 400mg/m2 on Day 1</description>
    <arm_group_label>Metastatic Esophageal, Gastroesophageal &amp; Gastric Cancer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluorouracil</intervention_name>
    <description>Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2</description>
    <arm_group_label>Metastatic Esophageal, Gastroesophageal &amp; Gastric Cancer</arm_group_label>
    <other_name>FU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Cisplatin (or Carboplatin) 40mg/m2 on Day 3</description>
    <arm_group_label>Metastatic Esophageal, Gastroesophageal &amp; Gastric Cancer</arm_group_label>
    <other_name>Carboplatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have metastatic disease of the esophagus, gastroesophageal junction or&#xD;
             stomach. Patients with locally recurrent disease who are not deemed eligible for&#xD;
             radiation are also permitted.&#xD;
&#xD;
          -  Histological, cytologic or radiographic documentation of metastatic adenocarcinoma or&#xD;
             squamous cell carcinoma of the esophagus, gastroesophageal junction or stomach.&#xD;
             Radiologic, endoscopic, histologic or cytologic evidence of locally recurrent disease&#xD;
             is also permitted.&#xD;
&#xD;
          -  Patients must be untreated with chemotherapy for metastatic or locally recurrent&#xD;
             disease. Prior radiation therapy is permitted.&#xD;
&#xD;
          -  Patients must have measurable disease as per RECIST 1.1, defined as at least one&#xD;
             lesion that can be accurately measured in at least one dimension (longest diameter to&#xD;
             be recorded for non-nodal lesions and short axis for nodal lesions) as &gt;20 mm with&#xD;
             conventional techniques or as &gt;10 mm with spiral CT scan, MRI, or calipers by clinical&#xD;
             exam. See Section 11 for the evaluation of measurable disease.&#xD;
&#xD;
          -  Age &gt;18 years and ≤ 80 years.&#xD;
&#xD;
          -  ECOG performance status &lt;2 (Karnofsky &gt;60%, see Appendix A).&#xD;
&#xD;
          -  Life expectancy of greater than 3 months.&#xD;
&#xD;
          -  Patients must have normal organ and marrow function.&#xD;
&#xD;
          -  Patients must not have any of the following conditions:&#xD;
&#xD;
          -  Recent major surgery, hormonal therapy (other than replacement) or chemotherapy,&#xD;
             within 4 weeks prior to entering the study or those who have not recovered from the&#xD;
             adverse events of treatment.&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to the chemotherapy on this trial.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for&#xD;
             nitrosoureas or mitomycin C) prior to entering the study or those who have not&#xD;
             recovered from adverse events due to agents administered more than 4 weeks earlier.&#xD;
&#xD;
          -  Patients who are receiving any investigational agents.&#xD;
&#xD;
          -  Patients with known brain metastases should be excluded from this clinical trial&#xD;
             because of their poor prognosis and because they often develop progressive neurologic&#xD;
             dysfunction that would confound the evaluation of neurologic and other adverse events.&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to the chemotherapy used in the study.&#xD;
&#xD;
          -  Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital,&#xD;
             or St John's Wort; these drugs induce CYP3A and may decrease levels of taxanes. 5-FU&#xD;
             is a strong CYP2C9 inducer, and concomitant use with carvedilol, celecoxib,&#xD;
             fosphenytoin, fluoxetine, phenytoin, warfarin and other CYP2C9 substrates should be&#xD;
             used with caution.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, unstable&#xD;
             cardiac arrhythmia, or psychiatric illness/social situations that would limit&#xD;
             compliance with study requirements.&#xD;
&#xD;
          -  Pregnant women are excluded from this study because chemotherapy has the potential for&#xD;
             teratogenic or abortifacient effects.&#xD;
&#xD;
          -  HIV-positive patients on combination antiretroviral therapy are ineligible because of&#xD;
             the potential for pharmacokinetic interactions with chemotherapeutic agents. In&#xD;
             addition, these patients are at increased risk of lethal infections when treated with&#xD;
             marrow-suppressive therapy. Appropriate studies will be undertaken in patients&#xD;
             receiving combination antiretroviral therapy when indicated.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ronan J Kelly, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>SKCCC at Johns Hopkins</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SKCCC at Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <results_first_submitted>February 19, 2019</results_first_submitted>
  <results_first_submitted_qc>March 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">March 15, 2019</results_first_posted>
  <last_update_submitted>March 14, 2019</last_update_submitted>
  <last_update_submitted_qc>March 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leucovorin</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>6 subjects were screen failures.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Metastatic Esophageal, Gastroesophageal &amp; Gastric Cancer</title>
          <description>Participants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.&#xD;
Docetaxel: Modified Docetaxel 40mg/m2 on Day 1&#xD;
Leucovorin: Leucovorin 400mg/m2 on Day 1&#xD;
Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2&#xD;
Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3</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>Metastatic Esophageal, Gastroesophageal &amp; Gastric Cancer</title>
          <description>Participants receive modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.&#xD;
Docetaxel: Modified Docetaxel 40mg/m2 on Day 1&#xD;
Leucovorin: Leucovorin 400mg/m2 on Day 1&#xD;
Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2&#xD;
Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3</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>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66" spread="9.70"/>
                  </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="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </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>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Response</title>
        <description>Number of participants treated with mDCF with progressive disease (PD), stable disease (SD), partial response (PR), non-complete response and non-progressive disease (non-CR/non-PD), and partial response with progressive disease clinically (PR/PD) as defined by RECIST criteria. Response is compared based on CHFR-methylation status.</description>
        <time_frame>4 months</time_frame>
        <population>Response could not be assessed in 2/21 participants since imaging was not evaluable, therefore RECIST reads could not be obtained.</population>
        <group_list>
          <group group_id="O1">
            <title>Metastatic Esophageal, Gastroesophageal &amp; Gastric Cancer.</title>
            <description>Participants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.&#xD;
Docetaxel: Modified Docetaxel 40mg/m2 on Day 1 Leucovorin: Leucovorin 400mg/m2 on Day 1 Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2 Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3</description>
          </group>
        </group_list>
        <measure>
          <title>Response</title>
          <description>Number of participants treated with mDCF with progressive disease (PD), stable disease (SD), partial response (PR), non-complete response and non-progressive disease (non-CR/non-PD), and partial response with progressive disease clinically (PR/PD) as defined by RECIST criteria. Response is compared based on CHFR-methylation status.</description>
          <population>Response could not be assessed in 2/21 participants since imaging was not evaluable, therefore RECIST reads could not be obtained.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CHFR-methylated</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>PD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PR</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>non-CR/non-PD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PR/PD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CHFR-unmethylated</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>PD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PR</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>non-CR/non-PD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PR/PD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown methylation status</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>PD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PR</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>non-CR/non-PD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PR/PD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CHFR Methylation Status</title>
        <description>Number of participants with advanced esophagogastric cancer that are CHFR-methylated or unmethylated at baseline.</description>
        <time_frame>Baseline</time_frame>
        <population>Only 18/21 participants had evaluable data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Metastatic Esophageal, Gastroesophageal &amp; Gastric Cancer.</title>
            <description>Participants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.&#xD;
Docetaxel: Modified Docetaxel 40mg/m2 on Day 1 Leucovorin: Leucovorin 400mg/m2 on Day 1 Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2 Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3</description>
          </group>
        </group_list>
        <measure>
          <title>CHFR Methylation Status</title>
          <description>Number of participants with advanced esophagogastric cancer that are CHFR-methylated or unmethylated at baseline.</description>
          <population>Only 18/21 participants had evaluable data for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CHFR-methylated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CHFR-unmethylated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>Number of participants alive at 2 years.</description>
        <time_frame>2 Years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Metastatic Esophageal, Gastroesophageal And Gastric Cancer.</title>
            <description>Participants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.&#xD;
Docetaxel: Modified Docetaxel 40mg/m2 on Day 1 Leucovorin: Leucovorin 400mg/m2 on Day 1 Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2 Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Number of participants alive at 2 years.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years.</time_frame>
      <desc>Only Grades 3 and 4 adverse events were collected for all patients.</desc>
      <group_list>
        <group group_id="E1">
          <title>Metastatic Esophageal, Gastroesophageal &amp; Gastric Cancer</title>
          <description>Patients received modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.&#xD;
Docetaxel: Modified Docetaxel 40mg/m2 on Day 1&#xD;
Leucovorin: Leucovorin 400mg/m2 on Day 1&#xD;
Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2&#xD;
Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE 4.03</default_vocab>
        <default_assessment>Non-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="19" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile Neutropenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Leukocytopenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE 4.03</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" 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" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Leukocytopenia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="16" subjects_affected="11" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotensive</sub_title>
                <counts group_id="E1" events="1" 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" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>GI Bleed</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization due to leg pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Fainting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Increased INR</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" 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>Ronan J. Kelly MD MBA</name_or_title>
      <organization>Baylor University Medical Center Dallas Texas</organization>
      <phone>214-820-2828</phone>
      <email>Ronan.Kelly@bswhealth.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/NCT01715233
org study id: J1248
secondary id: NA_00073720
nct id: NCT01715233
lead sponsor: 
has dmc: Yes
To estimate and compare the response rates in patients treated with mDCF based on methylation
      status of CHFR.
To estimate and compare the response rates in patients treated with mDCF based on methylation
      status of CHFR. The overall response rates in the un-methylated and methylated patient groups
      will be reported with a exact 95% binomial confidence interval. A chi-square test will be
      used for comparison.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Response
time frame: 4 months
description: Number of participants treated with mDCF with progressive disease (PD), stable disease (SD), partial response (PR), non-complete response and non-progressive disease (non-CR/non-PD), and partial response with progressive disease clinically (PR/PD) as defined by RECIST criteria. Response is compared based on CHFR-methylation status.
measure: CHFR Methylation Status
time frame: Baseline
description: Number of participants with advanced esophagogastric cancer that are CHFR-methylated or unmethylated at baseline.
measure: Overall Survival
time frame: 2 Years
description: Number of participants alive at 2 years.
arm group label: Metastatic Esophageal, Gastroesophageal & Gastric Cancer
arm group type: Experimental
description: Participants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.
intervention type: Drug
intervention name: Docetaxel
description: Modified Docetaxel 40mg/m2 on Day 1
arm group label: Metastatic Esophageal, Gastroesophageal & Gastric Cancer
other name: Modified DCF
intervention type: Drug
intervention name: Leucovorin
description: Leucovorin 400mg/m2 on Day 1
arm group label: Metastatic Esophageal, Gastroesophageal & Gastric Cancer
intervention type: Drug
intervention name: Fluorouracil
description: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2
arm group label: Metastatic Esophageal, Gastroesophageal & Gastric Cancer
other name: FU
intervention type: Drug
intervention name: Cisplatin
description: Cisplatin (or Carboplatin) 40mg/m2 on Day 3
arm group label: Metastatic Esophageal, Gastroesophageal & Gastric Cancer
other name: Carboplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ronan J Kelly, MD, MBA
role: Principal Investigator
affiliation: SKCCC at Johns Hopkins
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Leucovorin
mesh term: Carboplatin
mesh term: Docetaxel
mesh term: Fluorouracil
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 