Randomized phase II trial comparing amrubicine/irinotecan with cisplatin/irinotecan in patients with extensive-stage small-cell lung cancer: (JMTO LC 08-01)

INTERVENTION: A:Patients receive amrubicine on day 1 and irinotecan on days 1 and 8. Courses repeat every 3 weeks. B:Patients receive cisplatin on day 1 and irinotecan on days 1, 8, and 15. Courses repeat every 4 weeks. CONDITION: extensive‐disease small‐cell lung cancer PRIMARY OUTCOME: overall survival (1‐year survival rate) SECONDARY OUTCOME: progression free survival; response rate; safety (incidence of an adverse event) INCLUSION CRITERIA: 1) histologically or cytologically proven small‐cell lung cancer 2) extensive‐stage small‐cell lung cancer or limited‐stage small‐cell lung cancer with malignant pleural or pericardial effusion 3) no prior chemotherapy 4) performance status of 0 to 2 5) predicted life expectancy of 3 months 6) patients who has received palliative radiotherapy for brain or bone metastases can be included 7) adequate organ functions 8) measurable or unmeasurable disease 9) age 20 years or older 10) written informed consent