This single arm study will assess the efficacy and safety of Xeloda in combination with oxaliplatin as first-line chemotherapy in patients with advanced and/or metastatic gastric cancer who have had no prior chemotherapy for advanced or metastatic disease. Eligible patients will receive Xeloda 1000mg/m2 po twice daily, D1-D10 every 2 weeks (10 days treatment followed by 4 days rest period) plus oxaliplatin 85 mg/m2/day iv, D1 every 2 weeks. 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
45
85mg/m2 iv on day 1 of each 2 week cycle
1000mg/m2 po bid on days 1-10 of each 2 week cycle
Unnamed facility
Chai Yi, Taiwan
Unnamed facility
Chai Yi, Taiwan
Unnamed facility
Kaohsiung City, Taiwan
Unnamed facility
Keelung, Taiwan
Unnamed facility
Taichung, Taiwan
Unnamed facility
Taichung, Taiwan
Unnamed facility
Tainan, Taiwan
Unnamed facility
Tainan, Taiwan
Unnamed facility
Taipei, Taiwan
Unnamed facility
Taipei, Taiwan
...and 3 more locations
Overall response rate
Time frame: Event driven
Time to disease progression, overall survival, duration of response, time to response.
Time frame: Event driven
AEs, laboratory parameters.
Time frame: Throughout study
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