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Japanese Journal of Clinical Oncology Advance Access originally published online on June 11, 2009
Japanese Journal of Clinical Oncology 2009 39(9):576-581; doi:10.1093/jjco/hyp061
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© The Author (2009). Published by Oxford University Press. All rights reserved

A Phase I Study of Gemcitabine and Carboplatin in Patients with Advanced Non-small Cell Lung Cancer and a Performance Status of 2

Young Hak Kim1,2, Kaoru Kubota1, Koichi Goto1, Kiyotaka Yoh1, Seiji Niho1, Hironobu Ohmatsu1, Nagahiro Saijo1 and Yutaka Nishiwaki1

1 Division of Thoracic Oncology, National Cancer Center Hospital East, Chiba
2 Department of Respiratory Medicine, Kyoto University Hospital, Kyoto, Japan

For reprints and all correspondence: Young Hak Kim, Department of Respiratory Medicine, Kyoto University Hospital, 54 Shogoin-Kawaharacho, sakyo-ku, Kyoto 606-8507, Japan. E-mail: ekim{at}kuhp.kyoto-u.ac.jp

Received April 16, 2009; accepted May 7, 2009

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-naïve 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.

Key Words: non-small cell lung cancer • performance status 2 • gemcitabine • carboplatin • Phase I


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