Phase I study of weekly irinotecan combined with weekly cisplatin in patients with advanced solid tumors.
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%).


CONCLUSIONS
This combination seems to be active against lung cancer with acceptable toxicity. A phase II study is now ongoing.
Nakanishi
Yoichi
Y
Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. yoichi@kokyu.med.kyushu-u.ac.jp
Takayama
Koichi
K
Wataya
Hiroshi
H
Izumi
Miiru
M
Minami
Takahiro
T
Takano
Koichi
K
Inoue
Koji
K
Osaki
Shin'ichi
S
Kimotsuki
Kanehito
K
Harada
Taishi
T
Hara
Nobuyuki
N
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome
D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin