Phase 1/2 Study of S-1 and Cisplatin in Advanced Gastric Cancer

Inclusion Criteria

• •Has histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
• •Has advanced, unresectable cancer at the time of study entry
• •Has measurable disease as defined by RECIST criteria, i.e., lesions that can be accurately measured in at least one dimension with the longest diameter ≥20 mm using conventional techniques or ≥10 mm using spiral CT scan
• •Is at least 3 weeks post-gastrectomy surgery
• •Has not received prior chemotherapy for their cancer (adjuvant therapy is permitted and does not count as prior chemotherapy).
• •Has performance status of ≥ 70% on the Karnofsky scale (Appendix B)
• •Has a predicted life expectancy of ≥ 12 weeks
• •Has an absolute granulocyte count of ≥ 1,500/mm3
• •Has a platelet count ≥ 100,000/mm3
• •Has a hemoglobin of ≥ 9.0 g/dL
• •Has a bilirubin of ≤ 1.5 times the ULN
• •Has transaminases ≤ 2.5 times the ULN except for patients with liver metastasis who may have transaminases ≤ 5 times the ULN
• •Has a creatinine ≤ ULN and calculated creatinine ≥ 60 mL/min
• •According to the judgment of the Investigator, the patient has recovered from all previous anti-cancer treatment-related toxicities to at least Grade 1 (see exceptions above)
• •Has stopped all previous investigational drugs at least 4 weeks prior to treatment with S-1 and cisplatin.
• •Is able to take medications orally
• •Female patients of childbearing potential who are not pregnant and who use acceptable means of contraception while on study and for an additional 30 days after the last dose of study medication. Male patients must use adequate contraception.