Combination of Capecitabine and Oxaliplatin in Metastatic Nasopharyngeal Carcinoma
|ClinicalTrials.gov Identifier: NCT00363831|
Recruitment Status : Unknown
Verified July 2010 by The University of Hong Kong.
Recruitment status was: Recruiting
First Posted : August 15, 2006
Last Update Posted : July 28, 2010
- To evaluate the efficacy of capecitabine in combination with oxaliplatin (XELOX) in terms of overall response rate (based on RECIST criteria) in patients with metastatic NPC without prior chemotherapy for relapse.
- To evaluate the efficacy profile of oxaliplatin (XELOX) in patients with metastatic NPC in terms of time to progression of disease, survival time, duration of response and complete response rate.
- To study the safety and tolerability of the regimen in patients with metastatic NPC.
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Neoplasms||Drug: Oxaliplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center Phase II Trial of Capecitabine in Combination With Oxaliplatin (Xelox) as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma (NPC)|
|Study Start Date :||July 2006|
|Estimated Primary Completion Date :||December 2009|
130mg/m² infusion day 1, repeat every 21 days
- Overall response rate (based on RECIST criteria) [ Time Frame: From the beginning to the end of the study ]
- Time to progression [ Time Frame: From the beginning to the end of the study ]
- Overall survival time [ Time Frame: From the beginning to the end of the study ]
- Adverse events [ Time Frame: From the beginning to the end of the study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363831
|Contact: Public Registry GMA||PublicRegistryGMA@sanofi-aventis.com|
|Hong Kong, Hong Kong|
|Study Director:||Iris Chan||Sanofi|