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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
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).
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).
Unnamed facility
Hong Kong, Hong Kong
Unnamed facility
Hong Kong, Hong Kong
Unnamed facility
Yogyakarta, Indonesia
Unnamed facility
Kuala Lumpur, Malaysia
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
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Unnamed facility
Kueishan, Taiwan
Unnamed facility
Taipei, Taiwan
Unnamed facility
Taipei, Taiwan
Unnamed facility
Bangkok, Thailand
Unnamed facility
Bangkok, Thailand