title: A phase I trial of arterial infusion chemotherapy with gemcitabine and 5-fluorouracil for unresectable biliary tract cancer.
abstract: BACKGROUND
  Many clinical trials have been conducted with gemcitabine- or 5-fluorouracil-based regimens as treatment for unresectable biliary tract cancer; however, the results remain unsatisfactory. Because further therapeutic improvements are required, we conducted a phase I study of arterial infusion chemotherapy using a combination of gemcitabine and 5-fluorouracil.
  
  
  METHODS
  In the first 3 cohorts, patients were to receive an arterial infusion of gemcitabine 600, 800 or 1000 mg/m(2), respectively, over 30 min on days 1 and 15, plus a continuous arterial infusion of 5-fluorouracil 300 mg/m(2)/day on days 1-5 and 15-19. In the final cohort, patients were to receive an arterial infusion of gemcitabine 1000 mg/m(2) over 30 min on days 1 and 15, plus 5-fluorouracil 400 mg/m(2)/day on days 1-5 and 15-19.
  
  
  RESULTS
  Eighteen patients were enrolled. In the final cohort, three of six patients experienced grade 3 non-hematological toxicities (cholecystitis, cellulitis and pneumonia). Thus, we determined the maximum tolerated doses of gemcitabine and 5-fluorouracil in arterial infusion chemotherapy to be 1000 and 400 mg/m(2), respectively.
  
  
  CONCLUSIONS
  This regimen of gemcitabine and 5-fluorouracil is tolerable and warrants further investigation in biliary tract cancer.
authors.affiliation: Fourth Department of Internal Medicine, Sapporo Medical University School of Medicine, South-1, West-16, Chuo-ku, Sapporo, Hokkaido 060-8556, Japan. thayashi69@sapmed.ac.jp
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Hayashi
authors.forename: Hirotoshi
authors.initials: H
authors.lastname: Ishiwatari
authors.forename: Makoto
authors.initials: M
authors.lastname: Yoshida
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Sato
authors.forename: Koji
authors.initials: K
authors.lastname: Miyanishi
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Sato
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Kobune
authors.forename: Rishu
authors.initials: R
authors.lastname: Takimoto
authors.forename: Tomoko
authors.initials: T
authors.lastname: Sonoda
authors.forename: Junji
authors.initials: J
authors.lastname: Kato
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015331:Cohort Studies; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007263:Infusions, Parenteral; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D005472:Fluorouracil; D000093542:Gemcitabine