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

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ClinicalTrials.gov Identifier: NCT01481701
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a Phase II study for recurrent ovarian carcinoma platinum-sensitive and resistant tumors Folfox regimen.

Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Relapse Drug: Oxaliplatin Drug: oxaliplatin Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2008
Primary Completion Date : May 2014
Study Completion Date : May 2014


Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Objective response rate [ Time Frame: at 4 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT01481701     History of Changes
Other Study ID Numbers: Folfox
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: September 2013

Keywords provided by Jules Bordet Institute:
ovarian carcinoma
Bordet
relapse

Additional relevant MeSH terms:
Carcinoma
Recurrence
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Oxaliplatin
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs