title: A Phase II study of irinotecan in combination with 120-h infusion of 5-fluorouracil in patients with metastatic colorectal carcinoma: Japan Clinical Oncology Group Study (JCOG9703).
abstract: OBJECTIVE
  To evaluate the antitumor effect and feasibility of a combination of irinotecan (CPT-11) and 5-day infusional 5-fluorouracil (5-FU) in a sequential schedule based on our previous combination phase I studies in patients with metastatic colorectal cancer.
  
  
  METHODS
  Forty chemotherapy-naive patients with metastatic colorectal cancer received 90-min infusion of CPT-11 at a dose of 150 mg/m(2) on days 1 and 15 and 120-h protracted infusion of 5-FU at 600 mg/m(2)/day on days 3-7, which were repeated every 4 weeks.
  
  
  RESULTS
  The median number of actually administered courses was five, ranging from one to 14. There were 16 (40%) patients who developed grade 3 or 4 neutropenia. Grade 3 or 4 nausea/vomiting and diarrhea were seen in three (8%) and seven (18%) patients, respectively. Only one early death not related to treatment occurred during the study. There was one complete response and 17 partial responses with a response rate of 45% (95% confidence interval: 29.3-61.5%). With a median follow-up period of 22.5 months for survivors, the median survival and median progression-free survival times were 15.9 and 7.0 months, respectively.
  
  
  CONCLUSIONS
  Although the toxicities were modest, this sequentially combined regimen is active and feasible in patients with metastatic colorectal cancer.
authors.affiliation: Division of Gastrointestinal Oncology/Digestive Endoscopy, National Cancer Center Hospital East, Kashiwanoha, Kashiwa, Japan. aohstu@east.ncc.go.jp
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ohtsu
authors.forename: Narikazu
authors.initials: N
authors.lastname: Boku
authors.forename: Takashi
authors.initials: T
authors.lastname: Yoshioka
authors.forename: Ichinosuke
authors.initials: I
authors.lastname: Hyodo
authors.forename: Kuniaki
authors.initials: K
authors.lastname: Shirao
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimada
authors.forename: Soh
authors.initials: S
authors.lastname: Saitoh
authors.forename: Akira
authors.initials: A
authors.lastname: Nakamura
authors.forename: Noboru
authors.initials: N
authors.lastname: Yamamichi
authors.forename: Seiichiro
authors.initials: S
authors.lastname: Yamamoto
authors.forename: Shigeaki
authors.initials: S
authors.lastname: Yoshida
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin