NCT00439426

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasopharyngeal Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin	130mg/m2 iv on day 1 of each 3 week cycle
DRUG	capecitabine [Xeloda]	1000mg/m2 po bid on days 1-14 of each 3 week cycle

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2007-02-23
• Last updated: 2016-11-02

Locations

5 sites across 1 country: Morocco