Back to resultsA Trial Evaluating Efficacy and Safety of Oxaliplatin With 5-Fluorouracil in Patients With Recurrent Ovarian Carcinoma
Primary Purpose
Ovarian Carcinoma, Relapse
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Oxaliplatin
oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Carcinoma focused on measuring ovarian carcinoma, Bordet, relapse
Eligibility Criteria
Inclusion Criteria:
- ovarian carcinoma relapse
Exclusion Criteria:
- neurotoxicity grade III renal clearance < 60 ml/min
Sites / Locations
- Institut Jules Bordet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intravenous chemotherapy
Arm Description
treatment of ovarian carcinoma in relapse
Outcomes
Primary Outcome Measures
Objective response rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01481701
Brief Title
A Trial Evaluating Efficacy and Safety of Oxaliplatin With 5-Fluorouracil in Patients With Recurrent Ovarian Carcinoma
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 Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jules Bordet Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase II study for recurrent ovarian carcinoma platinum-sensitive and resistant tumors Folfox regimen.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Carcinoma, Relapse
Keywords
ovarian carcinoma, Bordet, relapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intravenous chemotherapy
Arm Type
Experimental
Arm Description
treatment of ovarian carcinoma in relapse
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
No other intervention
Intervention Description
85 mg/m² / 14days
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
oxaliplatin
Primary Outcome Measure Information:
Title
Objective response rate
Time Frame
at 4 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ovarian carcinoma relapse
Exclusion Criteria:
neurotoxicity grade III renal clearance < 60 ml/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronique D'Hondt, MD,PhD
Organizational Affiliation
Jules Bordet Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
A Trial Evaluating Efficacy and Safety of Oxaliplatin With 5-Fluorouracil in Patients With Recurrent Ovarian Carcinoma
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