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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2016
• Main ID: NCT02217956
• Date of registration: 14/08/2014
• Prospective Registration: No
• Primary sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Public title: Dose Escalation of Cisplatin Hyperthermic Intraperitoneal Chemotherapy After Surgery in Patients With Unresectable Stage IIIC Ovarian, Tube or Peritoneal Primary Adenocarcinoma CHIPASTIN
• Scientific 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
• Date of first enrolment: June 2011
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02217956
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

France

Key inclusion & exclusion criteria

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
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 Phosphatases alkaline
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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Fallopian Tube Adenocarcinoma

Primary Peritoneal Carcinoma

Ovarian Adenocarcinoma

Intervention(s)

Drug: Cisplatin

Drug: Bevacizumab

Primary Outcome(s)

Toxicity [Time Frame: Assessed at week 4 and 8 after HCIP then every 3 weeks up to 15 months]

Secondary Outcome(s)

Progression Free Survival [Time Frame: Assessed every 3 weeks from HCIP until progression up to 30 months]

Secondary ID(s)

2010-024361-51

2010/1699

Source(s) of Monetary Support

Please refer to primary and secondary sponsors