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CompletedNCT02217956CHIPASTINUpdated Aug 13, 2026

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

A Phase 1 interventional study of Cisplatin and Bevacizumab in Ovarian Adenocarcinoma, Fallopian Tube Adenocarcinoma and Primary Peritoneal Carcinoma, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Completed at 1 site in France. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Female
01

Study 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

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Conditions studied

  • Ovarian Adenocarcinoma
  • Fallopian Tube Adenocarcinoma
  • Primary Peritoneal Carcinoma
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In context

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

Interventions

  • DrugCisplatin
  • DrugBevacizumab
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What researchers measure

Primary outcomes

  1. Toxicity

    Using NCI CTCV4

    Time frame: Assessed at week 4 and 8 after HCIP then every 3 weeks up to 15 months

Secondary outcomes

  1. Progression Free Survival

    Time frame: Assessed every 3 weeks from HCIP until progression up to 30 months

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Study locations

1 site
  • Gustave Roussy
    Villejuif, Val de Marne 94805, France
08

References and documents

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. PubMed 27246305 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02217956
Lead sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Responsible party
Sponsor
First posted
Aug 15, 2014
Start date
Jun 2011
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Aug 13, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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