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Japanese Journal of Clinical Oncology 32:512-516 (2002)
© 2002 Foundation for Promotion of Cancer Research

A Phase I Study of Carboplatin and Docetaxel for Advanced Non-small Cell Lung Cancer Using the Continual Reassessment Method

Kazuo Kasahara1, Saori Myo1, Kei-ichi Iwasa2, Hideharu Kimura1, Hiroki Shirasaki1, Utako Yasuda1, Kazuhiko Shibata3, Hiromoto Shintani4, Kohichi Nishi2, Masaki Fujimura1 and Shinji Nakao1,+

1 Respiratory Medicine, School of Medicine, Kanazawa University, Kanazawa, 2 Respiratory Medicine, Ishikawa Prefectural Central Hospital, Kanazawa, 3 Division of Respiratory Medicine, Kouseiren Takaoka Hospital, Takaoka, Toyama and 4 Respiratory Medicine, Komatsu Municipal Hospital, Komatsu, Ishikawa, Japan

Purpose: This phase I study was designed to determine the maximum tolerated dose of carboplatin combined with a fixed dose of docetaxel (60 mg/m2) and the safety and efficacy of this combination chemotherapy in unresectable non-small cell lung cancer.

Methods: Patients received a 60 min intravenous infusion of docetaxel followed by a 90 min infusion of carboplatin with dose escalation using the continual reassessment method. The starting dose of carboplatin was targeted to an area under the plasma concentration curve of 3 using Calvert’s equation and dose escalation was based on course 1 toxicities.

Results: From January 1999 to February 2000, 16 patients entered this trial. The major dose-limiting toxicity was neutropenia. Thrombocytopenia was rare and major non-hematological toxicities included fever that was not associated with neutropenia and grade 2 nausea and vomiting. Objective responses were seen in five patients (response rate 31.3%).

Conclusions: Based on this phase I clinical trial, the maximum tolerated dose of carboplatin combined with 60 mg/m2 of docetaxel was a target area under the plasma concentration curve (tAUC) of 6 and the recommended tAUC for further trials is 5.5. This combination appeared to be effective for non-small cell lung cancer. A phase II clinical trial is recommended using 60 mg/m2 of docetaxel and carboplatin with a tAUC of 5.5.

+ For reprints and all correspondence: K. Kasahara, Respiratory Medicine, School of Medicine, Kanazawa University, Takara-machi 13–1, Kanazawa 920-8641, Japan. E-mail: kasa1237@med3.m.kanazawa-u.ac.jp


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