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

This study is currently recruiting participants.

Verified November 2011 by Jules Bordet Institute

Sponsor:

Information provided by (Responsible Party):

Jules Bordet Institute

ClinicalTrials.gov Identifier:

NCT01481701

First received: July 18, 2011

Last updated: March 14, 2013

Last verified: November 2011

History of Changes

Purpose

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

Condition	Intervention	Phase
Ovarian Carcinoma Relapse	Drug: Oxaliplatin Drug: oxaliplatin	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Fluorouracil Oxaliplatin

U.S. FDA Resources

Further study details as provided by Jules Bordet Institute:

Primary Outcome Measures:

Objective response rate [ Time Frame: at 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: intravenous chemotherapy treatment of ovarian carcinoma in relapse	Drug: Oxaliplatin 85 mg/m² / 14days Other Name: No other intervention Drug: oxaliplatin oxaliplatin

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ovarian carcinoma relapse

Exclusion Criteria:

neurotoxicity grade III renal clearance < 60 ml/min

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481701

Locations

Belgium
Institut Jules Bordet	Recruiting
Brussels, Belgium, 1000
Contact: Tatiana Besse, MD +3225413238 tatiana.besse-hammer@bordet.be
Contact: Fanny Bustin +3225413220 fanny.bustin@bordet.be
Principal Investigator: Veronique D'Hondt, MD,PhD

Sponsors and Collaborators

Jules Bordet Institute

Investigators

Principal Investigator:

Veronique D'Hondt, MD,PhD

Jules Bordet Institute

More Information

No publications provided

Responsible Party:	Jules Bordet Institute
ClinicalTrials.gov Identifier:	NCT01481701 History of Changes
Other Study ID Numbers:	Folfox
Study First Received:	July 18, 2011
Last Updated:	March 14, 2013
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Jules Bordet Institute:

ovarian carcinoma
Bordet
relapse

Additional relevant MeSH terms:

Ovarian Diseases
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases

Gonadal Disorders
Fluorouracil
Oxaliplatin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013

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