Patients Who Have Failed First Line Treatment for Locally Advanced and/or Metastatic Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT00782041|
Recruitment Status : Terminated (protocol violation)
First Posted : October 29, 2008
Last Update Posted : September 15, 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.
|Condition or disease||Intervention/treatment||Phase|
|Uterine Neoplasms||Drug: Oxaliplatin Drug: 5-FluoroUracil Drug: Folinic acid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||August 2003|
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.
Drug: Folinic acid
- Response rate [ Time Frame: Throughout the study period ]
- Progression-free survival [ Time Frame: Throughout the study period ]
- Overall survival [ Time Frame: Throughout the study period ]
- Adverse events [ Time Frame: Throughout the study period ]
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): NCT00782041
|Sanofi aventis administrative office|
|Study Director:||Paibulsirijit Sompob, MD||Sanofi|