<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/NCT01716546</url>
  </required_header>
  <id_info>
    <org_study_id>CT/09.10</org_study_id>
    <nct_id>NCT01716546</nct_id>
  </id_info>
  <brief_title>Trial of Panitumumab Cisplatin, Fluourouracil and Docetaxel in Locally Advanced or Metastatic Gastric Cancer</brief_title>
  <official_title>Phase I/II, Multicenter, Single-Arm Clinical Trial of Panitumumab in Combination With Cisplatin, Fluourouracil and Docetaxel (DCF) in Locally Advanced or Metastatic Cancer of the Stomach and Gastro-oesophageal Junction.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hellenic Oncology Research Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hellenic Oncology Research Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators propose to study the effect of panitumumab when combined with an active&#xD;
      regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in previously untreated patients&#xD;
      with advanced cancer of the stomach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators propose a phase I/II study in order to evaluate the effect of panitumumab when&#xD;
      combined with an active regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in&#xD;
      chemotherapy - naive patients with advanced cancer of the stomach.&#xD;
&#xD;
      Investigators hypothesize that the addition of panitumumab to DCF regimen in advanced cancer&#xD;
      of the stomach and gastroesophageal junction is feasible, well tolerated and could achieve an&#xD;
      objective response rate of greater than 40%.&#xD;
&#xD;
      The 2-weekly schedule of DCF will be used as chemotherapy since a recently presented trial&#xD;
      demonstrated a comparable efficacy but a more favourable toxicity profile comparable to the&#xD;
      3-weekly schedule.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Not reached the primary endpoint target according to the statistical design&#xD;
  </why_stopped>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 1/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>Objective response rate</measure>
    <time_frame>Every 8 weeks</time_frame>
    <description>Patients will be followed for disease evaluation every eight (8) weeks from the first day of chemotherapy until the first documentation of disease progression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>1 year</time_frame>
    <description>Patients will be evaluated from the date of the first chemotherapy cycle until the date of first documented progression or date of death from any cause, whichever came first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>1 year</time_frame>
    <description>Patients will be evaluated for overall survival from the date of the first chemotherapy cycle until the date of death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Tolerated Dose of the combination</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Patients will be evaluated for toxicity profil on Day 1 of the first two chemotherapy cycle (cycle repeated every 2 weeks)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Panitumumab plus DCF</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pazopanib</intervention_name>
    <arm_group_label>1</arm_group_label>
    <other_name>Pazopanib: 800mg once a day for up to 2 years from date of first dose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven inoperable locally advanced or metastatic adenocarcinoma of the&#xD;
             stomach (including adenocarcinoma of the gastrooesophageal junction)&#xD;
&#xD;
          -  Patient's age between 20 and 70 years old&#xD;
&#xD;
          -  Measurable disease defined by RECIST criteria&#xD;
&#xD;
          -  Patients with non-measurable disease could be enrolled in the phase I part of the&#xD;
             study&#xD;
&#xD;
          -  ECOG performance status ≤ 1&#xD;
&#xD;
          -  Hgb ≥ 8g/dL, WBC ≥ 3 x 109/L , neutrophils count ≥ 1.5 x 109/L , platelets ≥100 x&#xD;
             109/L, Creatinine clearance ≥50 mL/min, Total bilirubin ≤ 1.5 X UNL, AST, ALT and ALP&#xD;
             ≤ 2.5 x UNL&#xD;
&#xD;
          -  No prior chemotherapy or more than 6 months from adjuvant chemotherapy or&#xD;
             chemo-radiation&#xD;
&#xD;
          -  Estimated life expectancy more than 3 months&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastrointestinal bleeding&#xD;
&#xD;
          -  Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's&#xD;
             discomfort&#xD;
&#xD;
          -  CNS metastases&#xD;
&#xD;
          -  History of hypersensitivity to fluoropyrimidines, docetaxel or platinum compounds&#xD;
&#xD;
          -  Any previous chemotherapy or radiotherapy for advanced disease&#xD;
&#xD;
          -  Patient pregnant or breast feeding, or planning to become pregnant within 6 months&#xD;
             after the end of treatment&#xD;
&#xD;
          -  Patient (male or female) is not willing to use highly effective methods of&#xD;
             contraception (per institutional standard) during treatment and for 6 months (male or&#xD;
             female) after the end of treatment&#xD;
&#xD;
          -  Known hypersensitivity reaction to the component of the treatment&#xD;
&#xD;
          -  Active infection or malnutrition or bowel obstruction&#xD;
&#xD;
          -  Legal incapacity or limited legal capacity&#xD;
&#xD;
          -  Definite contraindications for the use of corticosteroids&#xD;
&#xD;
          -  History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or&#xD;
             evidence of interstitial lung disease on baseline chest CT scan&#xD;
&#xD;
          -  Chronic inflammation of the bowel&#xD;
&#xD;
          -  Clinically significant cardiovascular disease (including myocardial infarction,&#xD;
             unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac&#xD;
             arrhythmia) ≤ 1 year before enrollment&#xD;
&#xD;
          -  Medical or psychological condition which in the opinion of the investigator would not&#xD;
             permit the subject to complete the study or sign meaningful informed consent&#xD;
&#xD;
          -  A second primary tumor other than non-melanoma skin cancer or in situ cervical cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>&quot;IASO&quot; General Hospital of Athens</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>401 Military Hospital of Athens</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Air Forces Military Hospital of Athens</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Ag.Georgios&quot; General Hospital of Chania</name>
      <address>
        <city>Chania</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece</name>
      <address>
        <city>Heraklion</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State General Hospital of Larissa</name>
      <address>
        <city>Larissa</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Metaxa's&quot; Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology</name>
      <address>
        <city>Piraeus</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Theagenion&quot; Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology</name>
      <address>
        <city>Thessaloniki</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabalkaniko General Hospital of Thessaloniki</name>
      <address>
        <city>Thessaloniki</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 7, 2015</last_update_submitted>
  <last_update_submitted_qc>October 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Advanced cancer of the stomach</keyword>
  <keyword>Chemotherapy - naive patients</keyword>
  <keyword>DCF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01716546
org study id: CT/09.10
nct id: NCT01716546
lead sponsor: 
has dmc: No
Investigators propose to study the effect of panitumumab when combined with an active
      regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in previously untreated patients
      with advanced cancer of the stomach.
Investigators propose a phase I/II study in order to evaluate the effect of panitumumab when
      combined with an active regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in
      chemotherapy - naive patients with advanced cancer of the stomach.

      Investigators hypothesize that the addition of panitumumab to DCF regimen in advanced cancer
      of the stomach and gastroesophageal junction is feasible, well tolerated and could achieve an
      objective response rate of greater than 40%.

      The 2-weekly schedule of DCF will be used as chemotherapy since a recently presented trial
      demonstrated a comparable efficacy but a more favourable toxicity profile comparable to the
      3-weekly schedule.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate
time frame: Every 8 weeks
description: Patients will be followed for disease evaluation every eight (8) weeks from the first day of chemotherapy until the first documentation of disease progression
measure: Progression Free Survival
time frame: 1 year
description: Patients will be evaluated from the date of the first chemotherapy cycle until the date of first documented progression or date of death from any cause, whichever came first
measure: Overall Survival
time frame: 1 year
description: Patients will be evaluated for overall survival from the date of the first chemotherapy cycle until the date of death from any cause
measure: Maximum Tolerated Dose of the combination
time frame: Up to 4 weeks
description: Patients will be evaluated for toxicity profil on Day 1 of the first two chemotherapy cycle (cycle repeated every 2 weeks)
arm group label: 1
arm group type: Experimental
description: Panitumumab plus DCF
intervention type: Drug
intervention name: Pazopanib
arm group label: 1
other name: Pazopanib: 800mg once a day for up to 2 years from date of first dose
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Greece
responsible party type: Sponsor
mesh term: Stomach Neoplasms