title: [Phase I/II study of combination chemotherapy with gemcitabine and UFT for advanced pancreatic cancer in a multi-center trial].
abstract: The aim of this phase I/II study was to evaluate the tolerability and efficacy of combination chemotherapy with gemcitabine (GEM) and UFT for advanced pancreatic cancer. In phase I study UFT was given orally every day for 14 days and GEM was infused on day 1 and 8 at three dose levels (800, 900, 1,000 mg/m(2)/week) every 21 days. GEM 1,000 mg/m(2) and UFT 400 mg/m(2) did not reach the maximum tolerated dose. We decided that the recommended dose (RD) was GEM 1,000 mg/m(2)and UFT 400 mg/m(2). In phase II study 27 patients were enrolled and received GEM and UFT at RD. The tumor response rate was 17.6%, and the median survival was 221 days, which was very similar to that of GEM monotherapy. Due to adverse events, especially liver dysfunction, protocol therapy was discontinued in 12 patients. This study could not revealed the superiority of the GEM monotherapy.
authors.affiliation: Fukuoka Research Group for Pancreatic Cancer Chemotherapy.
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Sumii
authors.forename: Akihiro
authors.initials: A
authors.lastname: Funakoshi
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Mizumoto
authors.forename: Masao
authors.initials: M
authors.lastname: Tanaka
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Arita
authors.forename: Tetsuhide
authors.initials: T
authors.lastname: Ito
authors.forename: Hiroya
authors.initials: H
authors.lastname: Yamaguchi
authors.forename: Toshiharu
authors.initials: T
authors.lastname: Ueki
authors.forename: Terufumi
authors.initials: T
authors.lastname: Sakai
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Miyahara
authors.forename: Toru
authors.initials: T
authors.lastname: Muranaka
authors.forename: Hisato
authors.initials: H
authors.lastname: Igarashi
authors.forename: Hirotsugu
authors.initials: H
authors.lastname: Shinozaki
authors.forename: Naofumi
authors.initials: N
authors.lastname: Eriguchi
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D015996:Survival Rate; D005641:Tegafur / Q000009:adverse effects / Q000627:therapeutic use; D014498:Uracil / Q000009:adverse effects / Q000627:therapeutic use; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D005641:Tegafur; D014498:Uracil; D000093542:Gemcitabine