Clinical Trials/NCT01481701

NCT01481701

Completed

Phase 2

A Non Randomized Stratified Phase II Trial Evaluating Efficacy and Safety of Oxaliplatin in Combination With 5-Fluorouracil in Patients With Platinum-sensitive and Platinum-resistant Recurrent Ovarian Carcinoma

Jules Bordet Institute1 site in 1 country90 target enrollmentOctober 2008

ConditionsOvarian Carcinoma Relapse

Interventionsoxaliplatin

DrugsOxaliplatin oxaliplatin

Overview

Phase: Phase 2
Intervention: oxaliplatin
Conditions: Ovarian Carcinoma
Sponsor: Jules Bordet Institute
Enrollment: 90
Locations: 1
Primary Endpoint: Objective response rate
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

May 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Jules Bordet Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•ovarian carcinoma relapse

Exclusion Criteria

•neurotoxicity grade III renal clearance \< 60 ml/min

Arms & Interventions

intravenous chemotherapy

treatment of ovarian carcinoma in relapse

Intervention: oxaliplatin

Outcomes

Primary Outcomes

Objective response rate

Time Frame: at 4 years

Study Sites (1)

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