A phase I study of gemcitabine and carboplatin in patients with advanced non-small cell lung cancer and a performance status of 2

Abstract

Objective: The aim of this study was to determine the maximum-tolerated dose (MTD) and the recommended dose of combination chemotherapy with gemcitabine (GEM) and carboplatin (CBDCA) in non-small cell lung cancer (NSCLC) patients with a performance status (PS) of 2. Methods: Chemotherapy-näve NSCLC patients with PS 2 were enrolled. Chemotherapy consisted of an escalated dose of GEM on days 1 and 8 and CBDCA on day 1 every 3 weeks. Patients were scheduled to receive GEM (mg/ m2)/CBDCA (area under the curve: AUC) at four dose levels: 800/4 (level 1), 1000/4 (level 2), 1000/4.5 (level 3) and 1000/5 (level 4), respectively. Results: Between February 2004 and August 2006, 13 patients were enrolled in this study. Dose-limiting toxicities (DLTs) were thrombocytopenia, febrile neutropenia and hyponatremia. DLTs were observed in two of six patients at dose level 1 and in three of six patients at dose level 2. Dose level 2 was thus determined to be the MTD. Among 12 evaluable patients, 7 patients had stable diseases and 5 patients had progressive diseases, and the median survival time was 3.8 months. Conclusions: The MTD and the recommended dose for Phase II studies of this regimen were determined to be GEM 1000 mg/m2 and CBDCA AUC of 4. Additional objective measures are needed to evaluate patients' risk and benefit in future clinical trials for PS 2 patients. © The Author (2009). Published by Oxford University Press. All rights reserved.