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

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT02217956
Phase
PHASE1
Status
Completed

Conditions

  • Fallopian Tube Adenocarcinoma
  • Ovarian Adenocarcinoma
  • Primary Peritoneal Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

First listed
Aug 15, 2014
Start date
Jun 30, 2011
Status verified
Jan 2016
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

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