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

NCT02217956 | Completed Phase 1

• 2 other identifiers: 2010-024361-512010/1699
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Ovarian Adenocarcinoma; Fallopian Tube Adenocarcinoma; Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Toxicity

  Using NCI CTCV4

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

Secondary Outcomes (1)

• Progression Free Survival

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

Study Arms (1)

HCIP + bevacizumab

EXPERIMENTAL

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

Cisplatin DRUG

HCIP + bevacizumab

Bevacizumab DRUG

HCIP + bevacizumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \</= 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

You may not qualify if:

• Incomplete cell kill surgery
• Non-epithelial ovarian cancer
• Borderline tumors
• 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)
• Known hypersensitivity to platin or bevacizumab
• Not healed wound, ulcer or bone fracture
• Previous haemorrhagic or thrombotic malfunction \< 6 months
• Significant CArdiovascular disorder including:
• 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)

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

MeSH Terms

Interventions

Cisplatin; Bevacizumab

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 15, 2014
• Study Start: June 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 26, 2016

Record last verified: 2016-01

Locations

FR (1)