title: Phase I/II study of 24-hour infusion of irinotecan combined with oral UFT for metastatic colorectal cancer.
abstract: 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.
authors.affiliation: Department of Surgery, Tokai University School of Medicine, Isehara, Japan. sadahiro@is.icc.u-tokai.ac.jp
authors.forename: Sotaro
authors.initials: S
authors.lastname: Sadahiro
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Suzuki
authors.forename: Yuji
authors.initials: Y
authors.lastname: Maeda
authors.forename: Kenji
authors.initials: K
authors.lastname: Ishikawa
authors.forename: Seiei
authors.initials: S
authors.lastname: Yasuda
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Makuuchi
authors.forename: Chieko
authors.initials: C
authors.lastname: Murayama
mesh_terms: 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
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D005641:Tegafur; D014498:Uracil; D000077146:Irinotecan; D002166:Camptothecin