title: Phase I study of weekly irinotecan combined with weekly cisplatin in patients with advanced solid tumors.
abstract: 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.
authors.affiliation: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. yoichi@kokyu.med.kyushu-u.ac.jp
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Nakanishi
authors.forename: Koichi
authors.initials: K
authors.lastname: Takayama
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Wataya
authors.forename: Miiru
authors.initials: M
authors.lastname: Izumi
authors.forename: Takahiro
authors.initials: T
authors.lastname: Minami
authors.forename: Koichi
authors.initials: K
authors.lastname: Takano
authors.forename: Koji
authors.initials: K
authors.lastname: Inoue
authors.forename: Shin'ichi
authors.initials: S
authors.lastname: Osaki
authors.forename: Kanehito
authors.initials: K
authors.lastname: Kimotsuki
authors.forename: Taishi
authors.initials: T
authors.lastname: Harada
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Hara
mesh_terms: 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
chemical_list: D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin