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

October 14, 2014 updated by: Jules Bordet Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ovarian carcinoma relapse

Exclusion Criteria:

  • neurotoxicity grade III renal clearance < 60 ml/min

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: intravenous chemotherapy
treatment of ovarian carcinoma in relapse
Drug: Oxaliplatin
85 mg/m² / 14days
Other Names:
  • No other intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate
Time Frame: at 4 years
at 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jules Bordet Institute

Investigators

  • Principal Investigator: Veronique D'Hondt, MD,PhD, Jules Bordet Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

July 18, 2011

First Submitted That Met QC Criteria

November 25, 2011

First Posted (ESTIMATE)

November 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 14, 2014

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Folfox

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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