A phase I-II trial of topotecan and gemcitabine in patients with previously treated, advanced non-small cell lung cancer (LOA-3).

The purposes of this study were to determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), toxicity profile, and antitumor activity of topotecan (TOP) and gemcitabine (GEM) combination therapy when administered to patients with previously treated, advanced, non-small cell lung cancer. Both compounds were administered intravenously over 30 min, with TOP on days 1-5 and GEM on days 1 and 5 only. Nineteen patients were treated with 75 courses at three dose levels. The MTD was 0.75 and 400 mg/m2 for TOP and GEM, respectively, with thrombocytopenia and neutropenia as the DLTs. Partial responses were achieved in 3 of 17 patients (18%) with measurable disease. Six patients (32%) had disease stabilization for at least four courses of treatment. The median survival was 10 months from the initiation of TOP and GEM. This combination was relatively well tolerated and exhibited promising antitumor activity in patients with advanced, previously treated, non-small cell lung cancer.