Status:
COMPLETED
Dose Escalation of Cisplatin Hyperthermic Intraperitoneal Chemotherapy After Surgery in Patients With Unresectable Stage IIIC Ovarian, Tube or Peritoneal Primary Adenocarcinoma
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Ovarian Adenocarcinoma
Fallopian Tube Adenocarcinoma
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02217956
Start Date
June 1 2011
End Date
June 1 2015
Last Update
January 26 2016
Active Locations (1)
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1
Gustave Roussy
Villejuif, Val de Marne, France, 94805