 The pivotal phase III study which led to FDA approval of topotecan in relapsed small cell lung cancer was by Von Pawel et al, and included 211 subjects with sensitive 60 days since prior therapy relapse and randomized them to either topotecan 107 subjects daily for 5 days or to cyclophosphamide, doxorubicin, and vincristine CAV, each given every 21 days. Topotecan showed no significant improvement in the median time to progression 13.3 weeks vs.12.3 weeks, p0.552 or median survival 25 weeks vs. 24.7 weeks, p0.795, however, subjects treated with topotecan had improvement in cancer-related symptoms dyspnea, hoarseness, anorexia, and fatigue as well as hematologic toxicity. Irinotecan, has established activity in small cell lung cancer, as well as non-small cell lung cancer, colorectal cancer and ovarian cancer. 