A Trial Evaluating Efficacy and Safety of Oxaliplatin With 5-Fluorouracil in Patients With Recurrent Ovarian Carcinoma

Phase 2

Completed

• Conditions: Ovarian Carcinoma; Relapse
• Interventions: Drug: oxaliplatin

• Registration Number: NCT01481701
• Lead Sponsor: Jules Bordet Institute

Brief Summary

This is a Phase II study for recurrent ovarian carcinoma platinum-sensitive and resistant tumors Folfox regimen.

Detailed Description

Evaluation of the safety and the efficacy of a combination of oxaliplatin and 5FU (Folfox) in patients with ovarian carcinoma relapsing either after platinum-combined regimen.

The Folfox regimen is administered every 14 days. Evaluation of the toxicity is performed at each cycle and evaluation of the efficacy every 4 cycles of chemotherapy.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-11-25
• Study First Posted: 2011-11-29
• Status Verified: 2013-09
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• ovarian carcinoma relapse

Exclusion Criteria

• neurotoxicity grade III renal clearance < 60 ml/min

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intravenous chemotherapy	oxaliplatin	treatment of ovarian carcinoma in relapse

Primary Outcome Measures

Name	Time	Method
Objective response rate	at 4 years

Trial Locations

Locations (1)

Institut Jules Bordet; 🇧🇪 Brussels, Belgium