A Phase 2 interventional study of Capecitabine and Cisplatin in Nasopharyngeal Cancer, sponsored by Hoffmann-La Roche. Completed at 9 sites in 5 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-03-02.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
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.
240 studies on the registry are indexed under Nasopharyngeal Neoplasms; 47 are open to participants now.
This study's enrollment of 45 is below the median of 60 across 198 interventional studies indexed under Nasopharyngeal Neoplasms.
Browse Nasopharyngeal Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants with metastatic nasopharyngeal cancer will receive combination treatment with capecitabine (1000 milligrams per meter square \[mg/m\^2\] tablets twice daily \[BID\] orally) and cisplatin (100 mg/m\^2/day intravenous \[IV\] infusion) for up to 8 cycles.
Drug: Capecitabine · Drug: Cisplatin
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).
Also known as: Xeloda
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).
Overall response rate
Time frame: up to 28 days after the last intake of study treatment (up to approximately 5 years)
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
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche