A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.

A Open Label Study of the Effect of First-line Therapy With Xeloda in Combination With Oxaliplatin on Overall Response Rate in Patients With Locally Advanced and/or Metastatic Gastric Cancer

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.

Inclusion Criteria:

• adult patients, >=18 years of age;
• gastric cancer with unresectable locally advanced and/or metastatic disease;
• >=1 measurable lesion;
• ambulatory, with ECOG Performance Status >=1.

Exclusion Criteria:

• previous chemotherapy (except adjuvant or neoadjuvant treatment >=6 months prior to enrollment);
• clinically significant cardiac disease or myocardial infarction within last 12 months;
• CNS metastases;
• history of other malignancy within last 5 years, except for cured basal cell cancer of the skin, or in situ cancer of the cervix.