Objective: This study was conducted in refractory or relapsed small-cell lung cancer to determine activity and toxicity of the combination of cisplatin, ifosfamide, and irinotecan with rhG-CSF support. Methods: Eighteen patients entered the trial. The median chemotherapy-free interval was 3.1 (range 1.0-14.5) months. Cisplatin (20 mg/m(2)) and ifosfamide (1.5 g/m(2)) were administered on days 1-4, and irinotecan (60 mg/m(2)) was administered on days 1, 8, and 15. In patients who experienced grade 4 hematological toxicity during the prior chemotherapy, the doses of cisplatin and irinotecan were reduced to 15 and 50 mg/m(2), respectively. After 10 patients were entered, cisplatin and irinotecan were administered at doses of 15 and 50 mg/m(2), respectively. This regimen was repeated every 4 weeks, rhG-CSF was administered subcutaneously at a dose of 50 mu g/m(2) from days 50 to 18, except on the day of irinotecan treatment. Results: All patients could be assessed for response and toxicity. There were 1 complete and 16 partial responses, and an overall response rate of 94.4%. The median survival time of all patients was 339 days, and the 1-year survival rate was 47.5%. Hematological toxicities were significant. Grade 4 neutropenia and thrombocytopenia were observed in 61 and 33% of the patients, respectively. Diarrhea was mild and transient. There was no treatment-related death. Conclusion: The combination of cisplatin, ifosfamide, and irinotecan with rhG-CSF support was highly active for the treatment of refractory or relapsed small-cell lung cancer. Copyright (C) 2000 S. Karger AG, Basel.