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Japanese Journal of Clinical Oncology Advance Access published online on January 17, 2006

Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyi217
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© 2006 Foundation for Promotion of Cancer Research
Received July 21, 2005
Accepted December 1, 2005

Original Article

Phase I Study of Amrubicin Hydrochloride and Cisplatin in Patients Previously Treated for Advanced Non-small Cell Lung Cancer

Jiro Ikeda 1, Riichiroh Maruyama 1, Tatsuro Okamoto 1, Fumihiro Shoji 1, Hiroshi Wataya 1, and Yukito Ichinose 1 *

1 Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan

* To whom correspondence should be addressed.
Yukito Ichinose, E-mail: yichinos{at}nk-cc.go.jp


   Abstract

Objective: A single-center phase I trial was designed to determine both the dose-limiting toxicities and the maximum tolerated dose (MTD) for amrubicin hydrochloride in combination therapy with cisplatin for advanced non-small cell lung cancer (NSCLC) patients with prior chemotherapy.

Methods: Eligible patients received amrubicin and cisplatin on days 1 through 3 every 3 or 4 weeks. Cisplatin was administered at a fixed dosage of 20 mg/m2 while the administered dose of amrubicin was started at 20 mg/m2. Each group comprised 3 or 6 patients. When dose limiting toxicities were noted in three or more of six patients at a particular level, that level was estimated to be the MTD.

Results: Fifteen patients were enrolled in this study, including 5 males and 10 females, with a median age of 57. The dose limiting toxicities included grade 4 neutropenia which lasted 4 or more days and febrile neutropenia. The non-hematologic toxicities were well managed and rarely severe. The MTD of amrubicin in this combination regimen was estimated to be 30 mg/m2. A partial response was observed in 4 of 15 patients (27%).

Conclusions: The recommended dose was thus determined to be 25 mg/m2 amrubicin with 20 mg/m2 cisplatin for 3 consecutive days. A phase II study is currently underway.

Keywords: amrubicin hydrochloride; cisplatin; non-small cell lung cancer; phase I study; prior chemotherapy.
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