Phase 1 trial of lipoplatin and gemcitabine as a second‐line chemotherapy in patients with nonsmall cell lung carcinoma

BACKGROUND. Lipoplatin is a new liposomal cisplatin that already has been tested in solid tumors, with encouraging results. The purpose of the current study was to determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of a 21-day regimen of lipoplatin plus a fixed dose of gemcitabine in patients with refractory or resistant nonsmall cell lung carcinoma (NSCLC) with an Eastern Cooperative Oncology Group (ECOG) performance status of � 2. METHODS. The lipoplatin dose was escalated at 100 mg/m 2 by increments of 10 mg/m 2 on Days 1 and 8, with gemcitabine at a dose of 1000 mg/m 2 administered on Days 1 and 8, repeated every 21 days. Hematopoietic growth factors were not allowed. Thirteen patients with advanced stage NSCLC who had been pretreated with platinum combination chemotherapy were enrolled in this phase 1 trial. At least 3 patients were entered at each dose level.