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 (MT D), dose-limiting toxicity (DLT), toxicity profile, and antitumor activity of topotecan (TOP) and gemcitabine (GEM) combination therapy when administe red to patients with previously treated advanced, non-small cell lung cance l Both compounds were administered intravenously over 30 min, with TOP on d ays 1-5 and GEM on days 1 and 5 only. Nineteen patients were treated with 7 5 courses at three dose levels. The MTD was 0.75 and 400 mg/m(2) for TOP an d GEM, respectively, with thrombocytopenia and neutropenin as the DLTs. Par tial responses were achieved in 3 of 17 patients (18%) with measurable dise ase. 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 prom ising antitumour. activity in patients with advanced previously treated, no n-small cell lung cancer.