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Japanese Journal of Clinical Oncology 30:487-493 (2000)
© 2000 Foundation for Promotion of Cancer Research

Phase I Study of a Weekly Infusion of Irinotecan Hydrochloride (CPT-11) and a 14-day Continuous Infusion of Etoposide in Patients with Lung Cancer: JCOG Trial 9408

Mitsuhiro Fujishiro1, Tetsu Shinkai1,2, Minoru Fukuda1, Tomohide Tamura1, Yuichiro Ohe1, Hideo Kunitoh1, Yutaka Nishiwaki2, Ikuo Sekine1, Haruhiko Fukuda3 and Nagahiro Saijo1,+

1Division of Medical Oncology, National Cancer Center Hospital, Tokyo, 2Division of Medical Oncology, National Cancer Center Hospital East, Kashiwa, Chiba and 3Japan Clinical Oncology Group Data Center, Cancer Information and Epidemiology Division, National Cancer Center Research Institute, Tokyo, Japan

Background: The aim was to determine the maximum tolerated dose (MTD) and recommended dose of irinotecan hydrochloride (CPT-11) in combination with a 14-day continuous infusion of etoposide in patients with refractory advanced lung cancer (LC), especially small cell lung cancer (SCLC).

Methods: Etoposide was administered continuously at 25 mg/m2/day for 14 days. The initial dose of CPT-11 was 40 mg/m2 given as a 90 min intravenous infusion on days 1, 8 and 15 and the dose escalation of CPT-11 was planned in increments of 20 mg/m2 until severe or life-threatening toxic effects were observed.

Results: Nine refractory or advanced LC patients (eight at level 1, one at level 2) were entered in this study, of whom two at level 1 were not assessable for toxicity because of patient’s refusal and progressive disease. One treatment-related death due to pulmonary toxicity and one patient with hypotension who needed catecholamine for more than 48 h were observed at level 1, a CPT-11 dose of 40 mg/m2. The MTD of CPT-11 was 40 mg/m2. Therapeutic efficacy could be assessed in seven patients, of whom two achieved a partial response.

Conclusions: This regimen was too toxic and the recommended dose was outside the levels in this study. One has to consider pulmonary toxicity when using CPT-11, especially for patients previously treated with cytotoxic agents for which pulmonary toxicity has been reported.

+ For reprints and all correspondence: Tetsu Shinkai, Division of Medical Oncology, National Cancer Center Hospital East, 5–1, Kashiwanoha 6-chome, Kashiwa, Chiba, 277-8577, Japan. E-mail: tshinkai@ncc.go.jp


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