Purpose: This phase I study was designed to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of the paclitaxel-gemcitabine combination in a biweekly schedule in chemotherapy-naive patients with advanced non small-cell lung cancer (NSCLC).
Patients And Methods: Treatment was administered on an outpatient basis every 2 weeks: paclitaxel over a 1-h IV infusion and gemcitabine as a 30-min IV infusion immediately following paclitaxel.
Results: Twenty-nine patients were treated at six different dose levels, ranging from paclitaxel 135-175 mg/m2 and gemcitabine 1,500-3,000 mg/m2.