title: Optimal dose-finding study of bi-weekly paclitaxel in unresectable advanced or recurrent gastric cancer.
abstract: BACKGROUND
  Tri-weekly and weekly regimens of paclitaxel have been reported to be effective in unresectable advanced or recurrent gastric cancer. The present study was conducted to determine the optimal dose of bi-weekly paclitaxel and evaluate safety and antitumor effect.
  
  
  METHODS
  The study included patients with a histologically confirmed diagnosis of advanced or recurrent gastric cancer. Paclitaxel was intravenously infused for 1 h bi-weekly. One cycle consisted of four weeks and at least two cycles were performed. Dose levels 1, 2, 3, 4 and 5 were 100, 120, 140, 160 and 180 mg/m2, respectively.
  
  
  RESULTS
  Of the 21 patients enrolled, 18 patients (85.7%) had received prior treatment. The maximum tolerated dose was 160 mg/m2 (level 4) and dose-limiting toxicities included grade 3 fatigue, anorexia and neuropathy and grade 4 neutropenia and allergic reaction. The recommended dose was designated as to be 140 mg/m2 (level 3). At this dose level, only one patient experienced a dose-limiting toxicity of neutropenia. No patient had grade 3 or higher non-hematological toxicity. The response rate was 12.5% (2/16) and 14 patients (87.5%) had partial response or stable disease. The median number of treatment courses was four (up to 13 courses). The median survival time was 222 days and the time to progression was 76 days.
  
  
  CONCLUSIONS
  In advanced or recurrent gastric cancer, bi-weekly paclitaxel may be safely administered at a recommended dose of 140 mg/m2. A phase II study is now underway.
authors.affiliation: Department of Gastroenterology, Kitasato University East Hospital, 2-1-1 Asamizodai, Sagamihara, Kanagawa 228-8520, Japan. koizumi@med.kitasato-u.ac.jp
authors.forename: Wasaburo
authors.initials: W
authors.lastname: Koizumi
authors.forename: Satoshi
authors.initials: S
authors.lastname: Tanabe
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Higuchi
authors.forename: Toru
authors.initials: T
authors.lastname: Sasaki
authors.forename: Shosuke
authors.initials: S
authors.lastname: Nakayama
authors.forename: Kento
authors.initials: K
authors.lastname: Nakatani
authors.forename: Ken
authors.initials: K
authors.lastname: Nishimura
authors.forename: Takuya
authors.initials: T
authors.lastname: Shimoda
authors.forename: Mizutomo
authors.initials: M
authors.lastname: Azuma
authors.forename: Kenji
authors.initials: K
authors.lastname: Ishido
authors.forename: Katsunori
authors.initials: K
authors.lastname: Saigenji
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence
chemical_list: D000970:Antineoplastic Agents; D017239:Paclitaxel