Patients Who Have Failed First Line Treatment for Locally Advanced and/or Metastatic Cervical Cancer
This study has been terminated.
Information provided by:
First received: October 28, 2008
Last updated: September 14, 2009
Last verified: September 2009
- To assess the overall response rate of oxaliplatin in patients with bidimensionally measurable disease at baseline.
- To assess the safety and tolerability of oxaliplatin
- To assess time to progression and overall survival.
Drug: Folinic acid
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Oxaliplatin in Combination With 5-fluorouracil (5-FU) and Folinic Acid (FA) in Patients Who Have Failed First-line Treatment for Locally Advanced or Metastatic Cervical Cancer.|
Resource links provided by NLM:
Drug Information available for: Fluorouracil Folic acid Leucovorin calcium Oxaliplatin LevoleucovorinU.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Response rate [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
|Study Start Date:||January 2003|
|Primary Completion Date:||August 2003 (Final data collection date for primary outcome measure)|
Oxaliplatin 85 mg/m² over 3 hours at Day 1 and Day 15. 5-FU 2,000 mg/m² over 4 hours at Day 1. Folinic acid 20 mg/m² Bolus at Day 1.
85 mg/m²Drug: 5-FluoroUracil
2,000 mg/m²Drug: Folinic acid
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