Endometrial Cancer - LOHP Alone and With 5FU
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|ClinicalTrials.gov Identifier: NCT00612495|
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : February 11, 2008
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: oxaliplatin, 5 FU||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Parallel Randomised Open Phase II Study of Oxaliplatin (L-OHP) Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Locally Advanced or Metastatic Endometrial Cancer Previously Treated With Cisplatin or Arboplatin|
|Study Start Date :||January 2001|
|Study Completion Date :||March 2005|
Drug: oxaliplatin, 5 FU
Oxaliplatin:130 mg/m² as a 2-hour intravenous (IV) infusion in 500 mL of 5% glucose solution on Day 1 and repeated every 3 weeks.
5-FU: following oxaliplatin administration, 1000 mg/m²/day as a continuous IV infusion from Day 1 to Day 4, repeated every 3 weeks.
- Overall RR (World Health Organization [WHO]/Union Internationale Contre le Cancer [International Union Against Cancer] [UICC] criteria [ Time Frame: during the study conduct ]
- Progression free-survival, duration of response and overall survival. [ Time Frame: During the study conduct ]
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): NCT00612495
|Study Director:||Nathalie Billon||Sanofi|