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Japanese Journal of Clinical Oncology Advance Access originally published online on January 17, 2006
Japanese Journal of Clinical Oncology 2006 36(1):12-16; doi:10.1093/jjco/hyi217
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© 2006 Foundation for Promotion of Cancer Research

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

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

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

For reprints and all correspondence: Yukito Ichinose, Department of Thoracic Oncology, National Kyushu Cancer Center, 3-1-1, Notame, Minami-ku, Fukuoka 811-1395, Japan. E-mail: yichinos{at}nk-cc.go.jp

Received July 21, 2005; accepted December 1, 2005

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.

Key Words: amrubicin hydrochloride • cisplatin • non-small cell lung cancer • phase I study • prior chemotherapy


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