title: Phase I Dose-Escalation Study of Docetaxel, Cisplatin, and 5-Fluorouracil Combination Chemotherapy in Patients With Advanced Esophageal Carcinoma.
abstract: A dose-escalation study of docetaxel (DOC), cisplatin (CDDP), and 5-fluorouracil (5-FU; DCF combination regimen) was performed to determine the maximum-tolerated dose (MTD), recommended dose (RD) and dose-limiting toxicities (DLT) in advanced esophageal carcinoma. Eighteen patients with esophageal carcinoma were enrolled and received DCF combination therapy at different dose levels. DLTs included febrile neutropenia and oral mucositis. DLT occurred in 2 out of 6 patients at level 2 and 3. The study proceeded to level 4, according to the protocol. The level 4 dose was defined as the MTD and the level 3 dose was defined as the RD. The RD for DCF combination chemotherapy for advanced esophageal carcinoma in the present study was 70 mg/m(2) DOC plus 70 mg/m(2) CDDP on day 1 plus 700 mg/m(2) 5-FU on days 1-5 at 4-week intervals. This regimen was tolerable and highly active. A phase II study has been started.
authors.affiliation: Department of Surgery I, Dokkyo Medical University, Tochigi, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Satomura
authors.affiliation: Department of Surgery I, Dokkyo Medical University, Tochigi, Japan.
authors.forename: Masanobu
authors.initials: M
authors.lastname: Nakajima
authors.affiliation: Department of Surgery I, Dokkyo Medical University, Tochigi, Japan.
authors.forename: Kinro
authors.initials: K
authors.lastname: Sasaki
authors.affiliation: Department of Surgery I, Dokkyo Medical University, Tochigi, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Yamaguchi
authors.affiliation: Department of Surgery I, Dokkyo Medical University, Tochigi, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Domeki
authors.affiliation: Department of Surgery I, Dokkyo Medical University, Tochigi, Japan.
authors.forename: Masakazu
authors.initials: M
authors.lastname: Takahashi
authors.affiliation: Department of Surgery I, Dokkyo Medical University, Tochigi, Japan.
authors.forename: Hiroto
authors.initials: H
authors.lastname: Muroi
authors.affiliation: Department of Surgery I, Dokkyo Medical University, Tochigi, Japan.
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Kubo
authors.affiliation: Department of Surgery I, Dokkyo Medical University, Tochigi, Japan.
authors.forename: Maiko
authors.initials: M
authors.lastname: Kikuchi
authors.affiliation: Department of Surgery I, Dokkyo Medical University, Tochigi, Japan.
authors.forename: Haruka
authors.initials: H
authors.lastname: Otomo
authors.affiliation: Department of Surgery I, Dokkyo Medical University, Tochigi, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Ihara
authors.affiliation: Department of Surgery I, Dokkyo Medical University, Tochigi, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kato
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage*; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D011446:Prospective Studies; D043823:Taxoids / Q000008:administration & dosage*
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil
keywords: Cisplatin; Docetaxel; Esophagus; Fluorouracil; Phase I