Overview

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.