title: A phase I study of bi-weekly docetaxel for recurrent or advanced gastric cancer patients whose disease progressed by prior chemotherapy.
abstract: OBJECTIVE
  Although docetaxel is active against gastric cancer, Grade 3 or 4 neutropenia occurs in the majority of patients in Japan when administered at 60 mg/m(2) every 3 weeks. To determine a more convenient and tolerable schedule than the tri-weekly schedule, we conducted a dose-escalation study of bi-weekly docetaxel. In this study, we investigated the maximum-tolerated dose and recommended dose.
  
  
  METHODS
  Patients with advanced gastric cancer who had received prior chemotherapy were enrolled between April 2004 and March 2007. This study was designed to evaluate the escalated dose of docetaxel starting at 35 mg/m(2) (Level 1) given every 2 weeks. The dose was escalated in a stepwise fashion to 40 mg/m(2) (Level 2), 45 mg/m(2) (Level 3) and 50 mg/m(2) (Level 4).
  
  
  RESULTS
  Fifteen patients completed at least two cycles of the therapy. Three episodes of Grade 3 neutropenia occurred in all patients and Grade 4 neutropenia was observed at Level 4 in six patients. Grade 3 or 4 thrombocytopenia and anemia were not observed. Grade 3 aspartate aminotransferase/alanine aminotransferase elevation (n= 1) and Grade 3 stomatitis (n = 1) were noted at Level 4. There was no other Grade 3 or 4 non-hematologic toxicity. The definition of dose-limiting toxicities of this docetaxel schedule at Level 4 are Grade 4 neutropenia, Grade 3 aspartate aminotransferase/alanine aminotransferase elevation and Grade 3 stomatitis.
  
  
  CONCLUSIONS
  The maximum-tolerated dose of docetaxel when administrated following the bi-weekly schedule was 50 mg/m(2) and the recommended dose was 45 mg/m(2). Bi-weekly administration of docetaxel may provide a better tolerated and efficacious use in gastric cancer.
authors.affiliation: Department of Surgery, NTT West Osaka Hospital, 2-6-40 Karasugatuji, Tennojiku, Osaka 543-8922, Japan. y.kimura@mhc.west.ntt.co.jp
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Kimura
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yano
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Taniguchi
authors.forename: Takashi
authors.initials: T
authors.lastname: Iwazawa
authors.forename: Katsuki
authors.initials: K
authors.lastname: Danno
authors.forename: Naofumi
authors.initials: N
authors.lastname: Kagara
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Kanoh
authors.forename: Tadashi
authors.initials: T
authors.lastname: Ohnishi
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tono
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Nakano
authors.forename: Takushi
authors.initials: T
authors.lastname: Monden
authors.forename: Shingi
authors.initials: S
authors.lastname: Imaoka
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D018450:Disease Progression; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D018579:Patient Selection; D016879:Salvage Therapy / Q000379:methods*; D013274:Stomach Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects*; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase