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, Yukito Ichinose

Research output: Contribution to journalArticlepeer-review

5 Citations (Scopus)

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 cisplat in 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.

Original languageEnglish
Pages (from-to)12-16
Number of pages5
JournalJapanese journal of clinical oncology
Volume36
Issue number1
DOIs
Publication statusPublished - Jan 2006

All Science Journal Classification (ASJC) codes

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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