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Dose Escalation of Cisplatin Hyperthermic Intraperitoneal Chemotherapy After Surgery in Patients With Unresectable Stage IIIC Ovarian, Tube or Peritoneal Primary Adenocarcinoma (CHIPASTIN)

Primary Purpose

Ovarian Adenocarcinoma, Fallopian Tube Adenocarcinoma, Primary Peritoneal Carcinoma

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Cisplatin
Bevacizumab
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Adenocarcinoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Stage IIIC unresectable ovarian, tubes or peritoneal primitive adenocarcinoma according to FIGO classification previously treated with 6 cycles of carboplatin-cisplatin neoadjuvant chemotherapy with a response allowing complete surgery after the 6 cycles
  2. Time frame between the sixth platin injection and the CRS + HCIP < 10 weeks
  3. No disease progression during the neoadjuvant chemotherapy
  4. 18 </= âge </= 65 ans
  5. Performance Status OMS < 2
  6. Hematological function : PNN >/= 1.5x10^9/L, platelets >/= 150x10^9/L, hemoglobin > 9 g /dl (transfusion allowed)
  7. Hepatic function : Bilirubin </= 1,5 x LSN, ASAT (SGOT) and ALAT (SGPT) </= 3 x LSN, Phosphatases alkaline </= 3 x LSN
  8. No kidney related pathology, plasmatic creatinine < 140 µmol/l, creatinine clearance > 60 ml/min (Cockcroft formula) and urinary strip <2 (If urinary strip >/= 2, proteinuria < 1g/24h)
  9. Plasmatic albumine > 25 g/l
  10. HIV negative status
  11. Affiliation to social security
  12. Signed informed consent

Exclusion Criteria:

  1. Incomplete cell kill surgery
  2. Non-epithelial ovarian cancer
  3. Borderline tumors
  4. Non in complete remission previous cancer for more than 5 five years before inclusion
  5. Uncontrolled high blood pressure (blood pressure > 150/100 mm Hg despite antihypertensive treatment)
  6. Previous abdominal or pelvic radiotherapy
  7. Previous pathology of the central nervous system, except for well controlled pathology like epilepsy
  8. Previous stroke, transient ischemic attacks or subarachnoid hemorrhage
  9. Previous pulmonary embolism
  10. Pregnant or breastfeeding women (Women in age must have a blood negative pregnancy test at least 15 days before going under surgery)
  11. Participation to an other clinical trial within 30 days before inclusion in the study
  12. Known hypersensitivity to platin or bevacizumab
  13. Not healed wound, ulcer or bone fracture
  14. Previous haemorrhagic or thrombotic malfunction < 6 months

  15. Significant CArdiovascular disorder including:

    • Heart attack or unstable angina within the 6 months before inclusion
    • Grade > 1 congestive heart failure according to the NYHA classification
    • Uncontrolled cardiac arrhythmia despite of treatment (patients with atrial fibrillation for which the pace is under control can be include)
  16. Long term or recent (within 10 days before inclusion) medication using Aspirin at dosage > 325 mg/day
  17. Long term or recent (within 10 days before inclusion) medication using anticoagulant per os or parenteral or thrombolytic given at full dosage for therapeutic purpose.
  18. Grade > 1 previous sensory and motor neuropathies according to CTC AE V4.0
  19. Previous abdominal fistula, GI perforation or intra-abdominal abscess within 6 months before first administration of bevacizumab
  20. Proof of any other disease, metabolic malfunction, physical or laboratory exam showing any possibility of disease or condition contraindicating administration of the drug under trial or exsposing the patient to several complications related to the treatment.
  21. Persons deprived of liberty
  22. Impossibility to comply with the medical following of the treatment for geographical, social or mental reason

Sites / Locations

  • Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HCIP + bevacizumab

Arm 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

Outcomes

Primary Outcome Measures

Toxicity
Using NCI CTCV4

Secondary Outcome Measures

Progression Free Survival

Full Information

First Posted
August 14, 2014
Last Updated
January 25, 2016
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02217956
Brief Title
Dose Escalation of Cisplatin Hyperthermic Intraperitoneal Chemotherapy After Surgery in Patients With Unresectable Stage IIIC Ovarian, Tube or Peritoneal Primary Adenocarcinoma
Acronym
CHIPASTIN
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Adenocarcinoma, Fallopian Tube Adenocarcinoma, Primary Peritoneal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCIP + bevacizumab
Arm Type
Experimental
Arm 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(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Primary Outcome Measure Information:
Title
Toxicity
Description
Using NCI CTCV4
Time Frame
Assessed at week 4 and 8 after HCIP then every 3 weeks up to 15 months
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
Assessed every 3 weeks from HCIP until progression up to 30 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage IIIC unresectable ovarian, tubes or peritoneal primitive adenocarcinoma according to FIGO classification previously treated with 6 cycles of carboplatin-cisplatin neoadjuvant chemotherapy with a response allowing complete surgery after the 6 cycles Time frame between the sixth platin injection and the CRS + HCIP < 10 weeks No disease progression during the neoadjuvant chemotherapy 18 </= âge </= 65 ans Performance Status OMS < 2 Hematological function : PNN >/= 1.5x10^9/L, platelets >/= 150x10^9/L, hemoglobin > 9 g /dl (transfusion allowed) Hepatic function : Bilirubin </= 1,5 x LSN, ASAT (SGOT) and ALAT (SGPT) </= 3 x LSN, Phosphatases alkaline </= 3 x LSN No kidney related pathology, plasmatic creatinine < 140 µmol/l, creatinine clearance > 60 ml/min (Cockcroft formula) and urinary strip <2 (If urinary strip >/= 2, proteinuria < 1g/24h) Plasmatic albumine > 25 g/l HIV negative status Affiliation to social security Signed informed consent Exclusion Criteria: Incomplete cell kill surgery Non-epithelial ovarian cancer Borderline tumors Non in complete remission previous cancer for more than 5 five years before inclusion Uncontrolled high blood pressure (blood pressure > 150/100 mm Hg despite antihypertensive treatment) Previous abdominal or pelvic radiotherapy Previous pathology of the central nervous system, except for well controlled pathology like epilepsy Previous stroke, transient ischemic attacks or subarachnoid hemorrhage Previous pulmonary embolism Pregnant or breastfeeding women (Women in age must have a blood negative pregnancy test at least 15 days before going under surgery) Participation to an other clinical trial within 30 days before inclusion in the study Known hypersensitivity to platin or bevacizumab Not healed wound, ulcer or bone fracture Previous haemorrhagic or thrombotic malfunction < 6 months Significant CArdiovascular disorder including: Heart attack or unstable angina within the 6 months before inclusion Grade > 1 congestive heart failure according to the NYHA classification Uncontrolled cardiac arrhythmia despite of treatment (patients with atrial fibrillation for which the pace is under control can be include) Long term or recent (within 10 days before inclusion) medication using Aspirin at dosage > 325 mg/day Long term or recent (within 10 days before inclusion) medication using anticoagulant per os or parenteral or thrombolytic given at full dosage for therapeutic purpose. Grade > 1 previous sensory and motor neuropathies according to CTC AE V4.0 Previous abdominal fistula, GI perforation or intra-abdominal abscess within 6 months before first administration of bevacizumab Proof of any other disease, metabolic malfunction, physical or laboratory exam showing any possibility of disease or condition contraindicating administration of the drug under trial or exsposing the patient to several complications related to the treatment. Persons deprived of liberty Impossibility to comply with the medical following of the treatment for geographical, social or mental reason
Facility Information:
Facility Name
Gustave Roussy
City
Villejuif
State/Province
Val de Marne
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Learn more about this trial

Dose Escalation of Cisplatin Hyperthermic Intraperitoneal Chemotherapy After Surgery in Patients With Unresectable Stage IIIC Ovarian, Tube or Peritoneal Primary Adenocarcinoma

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