Phase I study of irinotecan and gemcitabine in previously untreated patients with advanced non-small cell lung cancer.
BACKGROUND
Irinotecan and gemcitabine are effective against non-small cell lung cancer. We conducted a phase I study of the combined use of irinotecan and gemcitabine in previously untreated patients with advanced non-small cell lung cancer to determine dose-limiting toxicities and maximum tolerated dose.


METHODS
Patients were treated with irinotecan followed by gemcitabine on days 1 and 8 every 3 weeks. Gemcitabine dose was fixed at 1000 mg/m2, and irinotecan dose was increased from 60 mg/m2.


RESULTS
A total of 16 patients was enrolled. Maximum tolerated dose of irinotecan was determined up to level 3 (irinotecan 100 mg/m2). In Japan, the maximum approved weekly dose of irinotecan is 100 mg/m2, so this was the dose that was used. Only very mild hematological and non-hematological toxicities were noted.


CONCLUSIONS
Use of 100 mg/m2 irinotecan followed by 1000 mg/m2 gemcitabine on days 1 and 8 every 3 weeks warrants a phase II study.
Takatani
Hiroshi
H
Department of Internal Medicine, Nagasaki Municipal Hospital, Nagasaki, Japan.
Soda
Hiroshi
H
Nakamura
Yoichi
Y
Kinoshita
Akitoshi
A
Fukuda
Masaaki
M
Nagashima
Seiji
S
Fukuda
Minoru
M
Soejima
Yoshifumi
Y
Nakano
Hirofumi
H
Oka
Mikio
M
Kohno
Shigeru
S
D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000633:toxicity; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000633:toxicity; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000633:toxicity; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000633:toxicity; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D016896:Treatment Outcome; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D003841:Deoxycytidine; D000077146:Irinotecan; D002166:Camptothecin; D000093542:Gemcitabine