AIM: To test protracted irinotecan infusion plus a low-dose cisplatin in this Phase Ⅱ trial to decrease its toxic-ity. METHODS: The eligibility criteria were: (1) histologi-cally proven measurable gastric cancer; (2) performance status of 0 or 1; (3) no prior chemotherapy or comple-tion of prior therapy at least 4 wk before enrollment; (4) adequate function of major organs; (5) no other active malignancy; and (6) written informed consent. The regi-men consisted of irinotecan (60 mg/m2) on d 1 and 15 by 24-h infusion and cisplatin (10 mg/m2) on d 1, 2, 3, 15, 16, and 17. Treatment was repeated every 4 wk. RESULTS: Thirty-one patients were registered between April 2000 and January 2001. The response rate for all 31 patients, 20 patients without prior chemotherapy, and 11 patients with prior chemotherapy was 52% (16/31), 60% (12/20), and 36% (4/11), respectively. The median survival time was 378 d. The median number of courses given to all patients was 2. Grade 4 neutropenia oc-curred in 11 (35%) patients, while grade 3 to 4 diarrhea or nausea occurred in 1 (3%) and 3 (10%) patients, respectively. Fatigue was minimal as grade 1 fatigue was found only in 3 (10%) patients. Other adverse events were mild and no treatment-related deaths occurred.CONCLUSION: This regimen showed a high level of ac-tivity and acceptable toxicity in patients with metastatic gastric cancer. METHODS: The eligibility criteria were: (1) histologi-cally proven measurable gastric cancer; (2) performance status of 0 (3) no prior chemotherapy or comple-tion of prior therapy at least 4 wk before enrollment; (4) adequate function of major organs; (5) no other active malignancy; and (6) written informed consent. -constant of irinotecan (60 mg / m 2) on d 1 and 15 by 24-h infusion and cisplatin (10 mg / m 2) on d 1, 2, 3, 15, 16, and 17. Treatment was repeated every 4 wk RESULTS: Thirty-one patients were registered between April 2000 and January 2001. The response rate for all 31 patients, 20 patients without prior chemotherapy, and 11 patients with prior chemotherapy was 52% (16/31), 60% (12 / 20), and 36% (4/11), respectively. The median survival time was 378 d. The median number of courses given to all patients was 2. Grade 4 neutropenia oc-curred i n 11 (35%) patients, while grade 3 to 4 diarrhea or nausea occurred in 1 (3%) and 3 (10%) patients, respectively. Fatigue was minimal as grade 1 fatigue was found only in 3 . Other adverse events were mild and no treatment-related deaths occurred. CONCLUSION: This regimen showed a high level of ac-tivity and acceptable toxicity in patients with metastatic gastric cancer.