NCT02608073

A Study of Capecitabine (Xeloda) as First-Line Chemotherapy in Participants With Metastatic Nasopharyngeal Cancer

A Multi-Center Phase II Trial of Capecitabine (Xeloda) in Combination With Cisplatin as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety, tolerability, and effect on quality of life of oral capecitabine in combination with intravenous (IV) cisplatin in participants with metastatic nasopharyngeal cancer. Participants will receive up to 8 cycles of capecitabine treatment, and cisplatin will be administered on the first day of each cycle. The anticipated time on study treatment is up to 24 weeks, and the target sample size is 44 individuals.

Conditions

• Nasopharyngeal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine	Participants will receive oral capecitabine, 1000 mg/m\^2 BID on Days 1 to 14 of each 21-day cycle, for up to 8 treatment cycles (24 weeks).
DRUG	Cisplatin	Participants will receive cisplatin, 100 mg/m\^2 via IV infusion on Day 1 of each 21-day cycle, for up to 8 treatment cycles (24 weeks).

Timeline

• Start date: 2004-11-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2015-11-18
• Last updated: 2016-03-02

Locations

9 sites across 5 countries: Hong Kong, Indonesia, Malaysia, Taiwan, Thailand