Clinical Trial: A Study of Capecitabine (Xeloda) as First-Line Chemotherapy in Participants With Metastatic Nasopharyngeal Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multi-Center Phase II Trial of Capecitabine (Xeloda) in Combination With Cisplatin as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma
Brief 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.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome: Overall response rate [ Time Frame: up to 28 days after the last intake of study treatment (up to approximately 5 years) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall survival [ Time Frame: Up to approximately 18 months ]
- Time to disease progression [ Time Frame: Up to approximately 18 months ]
- Duration of response [ Time Frame: Up to approximately 18 months ]
- Complete response rate [ Time Frame: Up to approximately 18 months ]
- Incidence of adverse events [ Time Frame: Up to approximately 7 months ]
- Quality of life according to Visual Analog Scale (VAS) score [ Time Frame: Up to approximately 6 months ]
- Treatment convenience/satisfaction according to VAS score [ Time Frame: Up to approximately 6 months ]
Original Secondary Outcome: Same as current
Information By: Hoffmann-La Roche
Dates:
Date Received: November 16, 2015
Date Started: November 2004
Date Completion:
Last Updated: March 1, 2016
Last Verified: March 2016
