Randomized phase II study of CPT-11 versus TXL versus each combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy (OGSG 0701)

INTERVENTION: A:CPT‐11(150mg/m2/day,day1) every 2 weeks B:TXL (80mg/m2, day1,8,15) every 4 weeks C:TS‐1 (80‐120mg/day, day1‐21), CPT‐11(80mg/m2/day, day1,15) every 5 weeks. D:TS‐1 (80‐120mg/day, day1pm day15am), TXL( 50mg/m2/day, day1,8) every 3 weeks. CONDITION: progressed/relapsed gastric cancer after TS‐1 or TS‐1/ platinum compounds chemotherapy PRIMARY OUTCOME: Overall survival time. SECONDARY OUTCOME: To determine the qualitative and quantitative toxicity and reversibility of toxicity of each chemotherapeutic regimen.; To estimate antitumor activity.; To estimate the progression free survival time. INCLUSION CRITERIA: 1) Patients who have not received prior antitumor chemotherapies without S‐1 or S‐1/CDDP treatment, immunotherapy, or radiotherapy (including local irradiation for pain control) as primary chemotherapy. 2) Patients who had received resistant for prior antitumor chemotherapy with S‐1 or S‐1/CDDP treatment as primary chemotherapy in whom either (a) or (b) below are diagnosed to be present by the principal investigator of the trial. (a) Advanced gastric cancer in which a new lesion or progression has been observed by diagnostic imaging after TS‐1 monotherapy or TS‐1/CDDP combination chemotherapy (either therapy for 4weeks or more) as primary chemotherapy for gastric cancer. (b) Recurrence during postoperative chemotherapy by TS‐1 monotherapy or within 26 weeks of its completion. 3) Patients in whom at least 2 weeks has passed since the completion of the previous chemotherapy. 4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 1,