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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT01481701
First received: July 18, 2011
Last updated: September 18, 2013
Last verified: September 2013

July 18, 2011
September 18, 2013
October 2008
October 2013   (final data collection date for primary outcome measure)
Objective response rate [ Time Frame: at 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01481701 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Trial Evaluating Efficacy and Safety of Oxaliplatin With 5-Fluorouracil in Patients With Recurrent Ovarian Carcinoma
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Carcinoma
  • Relapse
  • Drug: Oxaliplatin
    85 mg/m² / 14days
    Other Name: No other intervention
  • Drug: oxaliplatin
    oxaliplatin
Experimental: intravenous chemotherapy
treatment of ovarian carcinoma in relapse
Interventions:
  • Drug: Oxaliplatin
  • Drug: oxaliplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ovarian carcinoma relapse

Exclusion Criteria:

  • neurotoxicity grade III renal clearance < 60 ml/min
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01481701
Folfox
No
Jules Bordet Institute
Jules Bordet Institute
Not Provided
Principal Investigator: Veronique D'Hondt, MD,PhD Jules Bordet Institute
Jules Bordet Institute
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP