title: [Phase I study of gemcitabine (GEM) and UFT combination chemotherapy for unresectable/recurrent pancreatic cancer].
abstract: A phase I study of gemcitabine (GEM) and UFT combination chemotherapy was performed for unresectable pancreatic cancer. The regimen included UFT orally from day 1 through day 6 and from day 8 through 13, GEM intravenously on day 7 and 14, and 1 week rest as 1 course. Administration of more than 2 courses was attempted for each patient, with the same dosage levels at all 3 scheduled steps. Nine patients were enrolled in the study. Leukopenia and neutropenia of grade 3 occurred in 2 of 6 patients at level 2, and maximum tolerated dose (MTD) was considered to be 800 mg/m2 for GEM and 250 mg/m2 for UFT. Clinical effects of the patients included: 2 PR, 4 NC, and 3 PD, for a response rate of 22% (2/9 patients). Reduced CA19-9 level of less than half of that at starting time was observed in 4 of 9 (44%) patients. The recommended dose for the phase II study is GEM 800 mg/m2 and UFT 250 mg/m2 with consideration of application to outpatients and continuing courses.
authors.affiliation: Dept. of Surgery and Clinical Oncology, Graduate School of Medicine, Osaka University.
authors.forename: Shoji
authors.initials: S
authors.lastname: Nakamori
authors.forename: Masanori
authors.initials: M
authors.lastname: Tujie
authors.forename: Yuji
authors.initials: Y
authors.lastname: Takahashi
authors.forename: Shigeru
authors.initials: S
authors.lastname: Maruhashi
authors.forename: Atsushi
authors.initials: A
authors.lastname: Miyamoto
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Nagano
authors.forename: Keizo
authors.initials: K
authors.lastname: Dono
authors.forename: Koji
authors.initials: K
authors.lastname: Umeshita
authors.forename: Masato
authors.initials: M
authors.lastname: Sakon
authors.forename: Morito
authors.initials: M
authors.lastname: Monden
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D014498:Uracil / Q000008:administration & dosage / Q000009:adverse effects; D000093542:Gemcitabine
chemical_list: D004338:Drug Combinations; C096910:UFT(R) drug; D003841:Deoxycytidine; D005641:Tegafur; D014498:Uracil; D000093542:Gemcitabine