EXIBIT: Oxaliplatin in Biliary Tract Cancer
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|ClinicalTrials.gov Identifier: NCT00174564|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 17, 2012
The primary objective is to evaluate the efficacy of the GEMOX treatment as 1st line therapy in patients with advanced biliary tract cancer based on response rate measured by the RECIST unidimensional criteria.
Secondary objectives are : Progression free survival, overall survival and safety.
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Neoplasms||Drug: oxaliplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre Phase II Trial of Gemcitabine and Oxaliplatin (GEMOX) in Patients With Biliary Tract Cancer|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||September 2006|
- To evaluate response rate according to RECIST criteria
- To evaluate the progression-free survival in the ITT population
- To investigate safety using NCI-CTC criteria version 2
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): NCT00174564
|Study Director:||Jean-Philippe Aussel||Sanofi|