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

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Capecitabine; Oxaliplatin

Criteria

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.