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Phase I Study of Combination Chemotherapy With 5-Fluorouracil (5-FU) and Nedaplatin (NDP): Adverse Effects and Recommended Dose of NDP Administered After 5-FU

Fuwa, Nobukazu M.D.; Kodaira, Takeshi M.D.; Kamata, Minoru M.D.; Matsumoto, Akira M.D.; Furutani, Kazuhisa M.D.; Tachibana, Hiroyuki M.D.; Ito, Yoshiyuki M.D.

American Journal of Clinical Oncology: December 2002 - Volume 25 - Issue 6 - p 565-569

When nedaplatin (NDP) was used as a single agent in the phase I study, the dose-limiting toxicity (DLT) was thrombocytopenia and the recommended dose (RD) was 100 mg/m2. However, the DLT, maximum tolerated dose (MTD) and RD of NDP used in combination with 5-fluorouracil remained unknown. Therefore, we performed this study to assess the DLT and RD of NDP administered after 5-fluorouracil (5-FU). In this study, 5-FU was administered to 38 patients at a fixed dose (700 mg/m2/d on days 1–5) and NDP administered on day 6 at an initial dose of 80 mg/m2, which was subsequently increased to 100, 120, 130, 140, 150, and 160 mg/m2. The DLT of NDP was leukopenia and its MTD and RD were 160 and 150 mg/m2, respectively. Concerning impairment of renal function, only two patients had a grade I increase in serum creatinine. There were 19 responders (50%, 19/38) achieving partial response or complete response in the evaluation of antitumor effect. The result of this study is notable in that administration of 5-FU before NDP allows the dose of NDP to be substantially increased.

From the Department of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.

Address correspondence and reprint requests to Dr. Nobukazu Fuwa, Department of Radiation Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Japan. 464-0021.

© 2002 Lippincott Williams & Wilkins, Inc.