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NCT01481701 Clinical Trial

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

Ovarian Carcinoma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01481701
Other study ID # Folfox
Secondary ID
Status Completed
Phase Phase 2
First received July 18, 2011
Last updated October 14, 2014
Start date October 2008
Est. completion date May 2014

Study information
Verified date September 2013
Source Jules Bordet Institute
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ovarian carcinoma relapse

Exclusion Criteria:

- neurotoxicity grade III renal clearance < 60 ml/min

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Oxaliplatin
85 mg/m² / 14days
• oxaliplatin
oxaliplatin

Locations
Country Name City State
Belgium Institut Jules Bordet Brussels

Sponsors (1)
Lead Sponsor Collaborator
Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objective response rate at 4 years No
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