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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT01481701
First received: July 18, 2011
Last updated: October 14, 2014
Last verified: September 2013
  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:


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
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
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: October 14, 2014
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:
Carcinoma
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Fluorouracil
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014