Combination of Capecitabine and Oxaliplatin in Metastatic Nasopharyngeal Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
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): NCT00363831
|Contact: Public Registry GMA||PublicRegistryGMA@sanofi-aventis.com|
|Hong Kong, Hong Kong|
|Study Director:||Iris Chan||Sanofi|