Phase I/II study of 24-hour infusion of irinotecan combined with oral UFT for metastatic colorectal cancer.
BACKGROUND
To evaluate the efficacy and safety of irinotecan combined with UFT for untreated and pretreated metastatic colorectal cancer.


METHODS
Escalating doses of irinotecan (80-110 mg/m(2)) were administered by 24-hour infusion on day 1. UFT was administered orally at 400 mg/m(2)/day on days 3-7 and 10-14. The treatment cycles were repeated every 2 weeks.


RESULTS
In the phase I study, the maximum tolerated dose of irinotecan was 110 mg/m(2) and the recommended dose for the phase II study was determined to be 100 mg/m(2). Thirty-five patients including 3 patients at the recommended dose in the phase I study were evaluated in the phase II study. The grade 3/4 toxicities observed were leukopenia, neutropenia, thrombocytopenia and anemia. No grade 3 or more severe nonhematological toxicities were noted. The response rate was 62.9% and the median overall survival 16.7 months.


CONCLUSIONS
A 24-hour infusion of irinotecan combined with UFT is feasible and active for metastatic colorectal cancer.
Sadahiro
Sotaro
S
Department of Surgery, Tokai University School of Medicine, Isehara, Japan. sadahiro@is.icc.u-tokai.ac.jp
Suzuki
Toshiyuki
T
Maeda
Yuji
Y
Ishikawa
Kenji
K
Yasuda
Seiei
S
Makuuchi
Hiroyasu
H
Murayama
Chieko
C
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage; D014498:Uracil / Q000008:administration & dosage
D000972:Antineoplastic Agents, Phytogenic; D005641:Tegafur; D014498:Uracil; D000077146:Irinotecan; D002166:Camptothecin