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| ID | Type | Description | Link |
|---|---|---|---|
| 2010/1699 | Other Identifier | CSET number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCIP + bevacizumab | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug |
| ||
| Bevacizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Using NCI CTCV4 | Assessed at week 4 and 8 after HCIP then every 3 weeks up to 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Assessed every 3 weeks from HCIP until progression up to 30 months |
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Inclusion Criteria:
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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy | Villejuif | Val de Marne | 94805 | France |
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|
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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