A Study of Xeloda (Capecitabine) in Combination With XELOX (Oxaliplatin) in Patients With Metastatic Nasopharyngeal Cancer.

An Open Label Study of First Line Chemotherapy With Xeloda in Combination With Cisplatin on Treatment Response in Patients With Metastatic Nasopharyngeal Cancer

This single arm study will assess the efficacy and safety of Xeloda + oxaliplatin when given as first line treatment for patients with metastatic nasopharyngeal cancer. Patients will receive Xeloda (1000mg/m2 bid orally from day 1 to day 14, followed by a rest period of 7 days) plus oxaliplatin (130mg/m2 iv infusion on day 1 of each 21 day cycle) for 6-8 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Inclusion Criteria:

• adult patients, 18-75 years of age;
• history of nasopharyngeal cancer and distant metastases;
• no previous chemotherapy in past 6 months;
• recovery from previous radiotherapy;
• ability to swallow and retain oral medication.

Exclusion Criteria:

• previous cytotoxic chemotherapy;
• radiotherapy within 4 weeks of treatment start;
• history of another malignancy within the last 5 years;
• clinically significant cardiac disease.