Randomized phase III study of CPT-11 versus Weekly Paclitaxel for unresectable or recurrent gastric cancer refractory to combination chemotherapy with fluoropyrimidine plus platinum.

INTERVENTION: CPT‐11 Paclitaxel CONDITION: unresectable or recurrent gastric cancer refractory to combination chemotherapy with fluoropyrimidine plus platinum PRIMARY OUTCOME: overall survival SECONDARY OUTCOME: response rate, progression free survival, toxicity, rate of subsequent chemotherapy INCLUSION CRITERIA: 1.Histologically proven gastric adenocarcinoma 2.unresectable or recurrent gastric cancer refractory to one prior chemotherapy with fluorouracil plus platinum 3.No prior therapy of Taxane or CPT‐11 4.No severe peritoneal metastasis 5.Age 20‐75 years old 6.PS 0‐2 7.>14 days after prior chemotherapy 8.no history of chemotherapy for other malignancy and radiation to abdomen 9.Adequate organ functions a) WBC>3000/mm3 and <12000/mm3 b) Hb>8.0g/dL c) Plt>10*104/mm3 d) AST.ALT<100IU/L e) T‐Bil<1.5mg/dL f) Cre<1.5mg/dL 10.HBV(‐) 11.Written informed consent