Skip to main content
OpenTrials
Completed

NCT Number: NCT02217956

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ovarian Adenocarcinoma Fallopian Tube Adenocarcinoma Primary Peritoneal Carcinoma

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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:
  • 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

Treatment and study plan

Cisplatin

Drug

Bevacizumab

Drug

Primary outcomes

  1. Toxicity

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

    Using NCI CTCV4

Secondary outcomes

  1. Progression Free Survival

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

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study 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

Acronym: CHIPASTIN

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 15, 2014
Registry last updated
Jan 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.