| Inclusion Criteria: | 1) Has given written informed consent.
2) Has histologically confirmed, unresectable locally advanced (Stage cIV) or metastatic gastric adenocarcinoma, including adenocarcinoma of the gastro-esophageal junction. Histological confirmation is required at least for the first diagnosis. Gastro-esophageal (GE) junction adenocarcinoma (Types I, II and III) are eligible. Biopsy from esophagus is acceptable if the GE junction tumor extends to esophageal area with clear documentation.
3) No prior palliative chemotherapy for gastric cancer is permitted. Adjuvant and/or neo-adjuvant chemotherapy is permitted if more than 12 months has elapsed between the end of adjuvant or neo-adjuvant therapy and first recurrence. This does not qualify as 1st line therapy.
4) Is able to take medications orally.
5) Is >/=18 years of age.
6) First dose of study medication is at least 3 weeks from prior major surgery
7) First dose of study medication is at least 4 weeks from prior radiotherapy.
8) Has a ECOG performance status 0 to 1.
9) AST (SGOT) and ALT (SGPT) </=2.5 x ULN; if liver function abnormalities are due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) </= 5 x ULN.
10) Is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
11) Measurable Disease – Patients with measurable disease as defined by RECIST criteria, ie, the presence of at least one measurable lesion. A measurable lesion is one that can be accurately measured in at least one dimension with the longest diameter >/=20 mm using conventional techniques or >/=10 mm using spiral Computed Tomography (CT) scan. Locally recurrent disease, (other than primary) and Locally advanced disease is accepted if there is at least one measurable lesion other than the primary lesion (ie, peritoneal mass, lymph node, etc)
12) Evaluable but Non-measurable Disease. Patients with all lesions below the limits defined above for measurable disease (ie, longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT) excluding those patients with only a primary lesion and/or with only non-evaluable cancer such as bone metastases, ascites, pleural or pericardial effusions, lymphangitic carcinomatosis of the skin or lung, previously irradiated lesions not in progression, or peritoneal carcinomatosis < 10 mm in diameter whether with conventional imaging techniques or spiral CT.
13) Total serum bilirubin of </=1.5 x ULN.
14) Absolute granulocyte count of >/=1,500/mm(3) (ie, >/=1.5 x 10(9)/L by International Units [IU]).
15) Platelet count >/=100,000/mm(3) (IU: >/=100 x 10(9)/L).
16) Hemoglobin value of >/=9.0 g/dL based on measurements obtained prior to any transfusions during the screening period.
17) Calculated creatinine clearance >/= 60 mL/min (calculated by Cockcroft-Gault formula see Appendix E, or based on 24-hour urine collection). |