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

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

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

Study Overview

• Status: Completed
• Conditions: Fallopian Tube Adenocarcinoma; Ovarian Adenocarcinoma; Primary Peritoneal Carcinoma
• Intervention / Treatment: Drug: Cisplatin; Drug: Bevacizumab

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Val de Marne
    • Villejuif, Val de Marne, France, 94805
      • Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HCIP + bevacizumab; 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	Drug: Cisplatin; Drug: Bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity	Using NCI CTCV4	Assessed at week 4 and 8 after HCIP then every 3 weeks up to 15 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival	Assessed every 3 weeks from HCIP until progression up to 30 months

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

General Publications

• Gouy S, Ferron G, Glehen O, Bayar A, Marchal F, Pomel C, Quenet F, Bereder JM, Le Deley MC, Morice P. Results of a multicenter phase I dose-finding trial of hyperthermic intraperitoneal cisplatin after neoadjuvant chemotherapy and complete cytoreductive surgery and followed by maintenance bevacizumab in initially unresectable ovarian cancer. Gynecol Oncol. 2016 Aug;142(2):237-42. doi: 10.1016/j.ygyno.2016.05.032. Epub 2016 Jun 2.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: August 14, 2014
• First Submitted That Met QC Criteria: August 14, 2014
• First Posted (Estimated): August 15, 2014

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 11, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds; Bevacizumab; Cisplatin
• Other Study ID Numbers: 2010-024361-51; 2010/1699 (Other Identifier: CSET number)