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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
130mg/m2 iv on day 1 of each 3 week cycle
1000mg/m2 po bid on days 1-14 of each 3 week cycle
Unnamed facility
Agadir, Morocco
Unnamed facility
Casablanca, Morocco
Unnamed facility
Marrakesh, Morocco
Unnamed facility
Rabat, Morocco
Unnamed facility
Rabat, Morocco
Overall response rate
Time frame: Event driven
Time to disease progression or death, survival time, duration of response, complete response rate.
Time frame: Event driven
AEs, laboratory parameters.
Time frame: Throughout study
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