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Phase I study of weekly irinotecan combined with weekly cisplatin in patients with advanced solid tumors
Yoichi Nakanishi1, Koichi Takayama, Hiroshi Wataya
1Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. yoichi@kokyu.med.kyushu-u.ac.jp
Background:
Previous studies have reported a synergistic effect between irinotecan and cisplatin. We have conducted a phase I trial combining these agents to find the optimal dose of irinotecan in combination with a fixed dose of cisplatin.
Methods:
Patients with advanced solid tumors, aged < or =75 years, performance status < or =2, and adequate organ function were enrolled in this study. They were treated at 4-week intervals with irinotecan plus 20 mg/m(2) cisplatin on days 1, 8, and 15. The starting dose of irinotecan of 40 mg/m(2) was escalated in 10 mg/m(2) increments until a maximum dose of 90 mg/m(2) was reached.
Results:
The recommended dose for phase II studies is 90 mg/m(2) of irinotecan and 20 mg/m(2) of cisplatin on days 1, 8, and 15. Overall response to the chemotherapy was 35% (95% confidential interval, 19.2-54.6%).
Conclusion:
This combination seems to be active against lung cancer with acceptable toxicity. A phase II study is now ongoing.