<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/NCT02217956</url>
  </required_header>
  <id_info>
    <org_study_id>2010-024361-51</org_study_id>
    <secondary_id>2010/1699</secondary_id>
    <nct_id>NCT02217956</nct_id>
  </id_info>
  <brief_title>Dose Escalation of Cisplatin Hyperthermic Intraperitoneal Chemotherapy After Surgery in Patients With Unresectable Stage IIIC Ovarian, Tube or Peritoneal Primary Adenocarcinoma</brief_title>
  <acronym>CHIPASTIN</acronym>
  <official_title>Phase I Study of Cisplatin Hyperthermic Intraperitoneal Chemotherapy Dose Escalation After Surgery in Patients With Unresectable Stage IIIC Ovarian, Tube or Peritoneal Primary Adenocarcinoma Previously Treated by Chemotherapy and Completed by Bevacizumab for 15 Months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gustave Roussy, Cancer Campus, Grand Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gustave Roussy, Cancer Campus, Grand Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      HCIP has shown efficacy in treatment of peritoneal carcinosis from colorectal background. Few&#xD;
      studies have been published on the use of HCIP in peritoneal carcinosis from ovarian&#xD;
      background but most of them were non-randomized phase II studies on a small population using&#xD;
      different type of drugs and dosage. before this heterogeneity it seems necessary to&#xD;
      standardize the utilization modalities of HCIP in peritoneal carcinosis from ovarian&#xD;
      background&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Toxicity</measure>
    <time_frame>Assessed at week 4 and 8 after HCIP then every 3 weeks up to 15 months</time_frame>
    <description>Using NCI CTCV4</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>Assessed every 3 weeks from HCIP until progression up to 30 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Ovarian Adenocarcinoma</condition>
  <condition>Fallopian Tube Adenocarcinoma</condition>
  <condition>Primary Peritoneal Carcinoma</condition>
  <arm_group>
    <arm_group_label>HCIP + bevacizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 dose level of cisplatin are planned: Level 1 : 50 mg/m2 (start level) Level 2 : 60 mg/m2 Level 3 : 70 mg/m2 Level 4 : 80 mg/m2 Level -1: 40 mg/m2 (in case of DLT at level 1)&#xD;
bevacizumab: Treatment starts between week 10 and 14 after HCIP. Dosage: 15 mg/kg for a total of 22 injections every 3 weeks for 15 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <arm_group_label>HCIP + bevacizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <arm_group_label>HCIP + bevacizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Stage IIIC unresectable ovarian, tubes or peritoneal primitive adenocarcinoma&#xD;
             according to FIGO classification previously treated with 6 cycles of&#xD;
             carboplatin-cisplatin neoadjuvant chemotherapy with a response allowing complete&#xD;
             surgery after the 6 cycles&#xD;
&#xD;
          2. Time frame between the sixth platin injection and the CRS + HCIP &lt; 10 weeks&#xD;
&#xD;
          3. No disease progression during the neoadjuvant chemotherapy&#xD;
&#xD;
          4. 18 &lt;/= âge &lt;/= 65 ans&#xD;
&#xD;
          5. Performance Status OMS &lt; 2&#xD;
&#xD;
          6. Hematological function : PNN &gt;/= 1.5x10^9/L, platelets &gt;/= 150x10^9/L, hemoglobin &gt; 9&#xD;
             g /dl (transfusion allowed)&#xD;
&#xD;
          7. Hepatic function : Bilirubin &lt;/= 1,5 x LSN, ASAT (SGOT) and ALAT (SGPT) &lt;/= 3 x LSN,&#xD;
             Phosphatases alkaline &lt;/= 3 x LSN&#xD;
&#xD;
          8. No kidney related pathology, plasmatic creatinine &lt; 140 µmol/l, creatinine clearance &gt;&#xD;
             60 ml/min (Cockcroft formula) and urinary strip &lt;2 (If urinary strip &gt;/= 2,&#xD;
             proteinuria &lt; 1g/24h)&#xD;
&#xD;
          9. Plasmatic albumine &gt; 25 g/l&#xD;
&#xD;
         10. HIV negative status&#xD;
&#xD;
         11. Affiliation to social security&#xD;
&#xD;
         12. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Incomplete cell kill surgery&#xD;
&#xD;
          2. Non-epithelial ovarian cancer&#xD;
&#xD;
          3. Borderline tumors&#xD;
&#xD;
          4. Non in complete remission previous cancer for more than 5 five years before inclusion&#xD;
&#xD;
          5. Uncontrolled high blood pressure (blood pressure &gt; 150/100 mm Hg despite&#xD;
             antihypertensive treatment)&#xD;
&#xD;
          6. Previous abdominal or pelvic radiotherapy&#xD;
&#xD;
          7. Previous pathology of the central nervous system, except for well controlled pathology&#xD;
             like epilepsy&#xD;
&#xD;
          8. Previous stroke, transient ischemic attacks or subarachnoid hemorrhage&#xD;
&#xD;
          9. Previous pulmonary embolism&#xD;
&#xD;
         10. Pregnant or breastfeeding women (Women in age must have a blood negative pregnancy&#xD;
             test at least 15 days before going under surgery)&#xD;
&#xD;
         11. Participation to an other clinical trial within 30 days before inclusion in the study&#xD;
&#xD;
         12. Known hypersensitivity to platin or bevacizumab&#xD;
&#xD;
         13. Not healed wound, ulcer or bone fracture&#xD;
&#xD;
         14. Previous haemorrhagic or thrombotic malfunction &lt; 6 months&#xD;
&#xD;
         15. Significant CArdiovascular disorder including:&#xD;
&#xD;
               -  Heart attack or unstable angina within the 6 months before inclusion&#xD;
&#xD;
               -  Grade &gt; 1 congestive heart failure according to the NYHA classification&#xD;
&#xD;
               -  Uncontrolled cardiac arrhythmia despite of treatment (patients with atrial&#xD;
                  fibrillation for which the pace is under control can be include)&#xD;
&#xD;
         16. Long term or recent (within 10 days before inclusion) medication using Aspirin at&#xD;
             dosage &gt; 325 mg/day&#xD;
&#xD;
         17. Long term or recent (within 10 days before inclusion) medication using anticoagulant&#xD;
             per os or parenteral or thrombolytic given at full dosage for therapeutic purpose.&#xD;
&#xD;
         18. Grade &gt; 1 previous sensory and motor neuropathies according to CTC AE V4.0&#xD;
&#xD;
         19. Previous abdominal fistula, GI perforation or intra-abdominal abscess within 6 months&#xD;
             before first administration of bevacizumab&#xD;
&#xD;
         20. Proof of any other disease, metabolic malfunction, physical or laboratory exam showing&#xD;
             any possibility of disease or condition contraindicating administration of the drug&#xD;
             under trial or exsposing the patient to several complications related to the&#xD;
             treatment.&#xD;
&#xD;
         21. Persons deprived of liberty&#xD;
&#xD;
         22. Impossibility to comply with the medical following of the treatment for geographical,&#xD;
             social or mental reason&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <state>Val de Marne</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>January 25, 2016</last_update_submitted>
  <last_update_submitted_qc>January 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2016</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>Adenocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</mesh_term>
  </intervention_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/NCT02217956
org study id: 2010-024361-51
secondary id: 2010/1699
nct id: NCT02217956
lead sponsor: 
has dmc: No
HCIP has shown efficacy in treatment of peritoneal carcinosis from colorectal background. Few
      studies have been published on the use of HCIP in peritoneal carcinosis from ovarian
      background but most of them were non-randomized phase II studies on a small population using
      different type of drugs and dosage. before this heterogeneity it seems necessary to
      standardize the utilization modalities of HCIP in peritoneal carcinosis from ovarian
      background
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Toxicity
time frame: Assessed at week 4 and 8 after HCIP then every 3 weeks up to 15 months
description: Using NCI CTCV4
measure: Progression Free Survival
time frame: Assessed every 3 weeks from HCIP until progression up to 30 months
arm group label: HCIP + bevacizumab
arm group type: Experimental
description: 4 dose level of cisplatin are planned: Level 1 : 50 mg/m2 (start level) Level 2 : 60 mg/m2 Level 3 : 70 mg/m2 Level 4 : 80 mg/m2 Level -1: 40 mg/m2 (in case of DLT at level 1)
bevacizumab: Treatment starts between week 10 and 14 after HCIP. Dosage: 15 mg/kg for a total of 22 injections every 3 weeks for 15 months
intervention type: Drug
intervention name: Cisplatin
arm group label: HCIP + bevacizumab
intervention type: Drug
intervention name: Bevacizumab
arm group label: HCIP + bevacizumab
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Bevacizumab