title: Weekly docetaxel, cisplatin, and irinotecan (TPC): results of a multicenter phase II trial in patients with metastatic esophagogastric cancer.
abstract: BACKGROUND
  Recent studies have examined the addition of docetaxel to fluorouracil and cisplatin in advanced esophagogastric cancer.
  
  
  METHODS
  We carried out a phase I dose-escalation study of weekly docetaxel, cisplatin, and irinotecan (TPC), given on days 1 and 8 every 3 weeks, in patients with chemonaive solid tumors. Subsequently, we completed a multiinstitutional phase II study of TPC in patients with previously untreated, metastatic esophagogastric cancer.
  
  
  RESULTS
  Thirty-nine patients were enrolled in the phase I trial; a weekly schedule of TPC was well tolerated. On that basis, docetaxel 30 mg/m(2), cisplatin 25 mg/m(2), and irinotecan 65 mg/m(2) were selected for the phase II trial, where in the first 18 patients irinotecan 65 mg/m(2) caused too much diarrhea and was reduced to 50 mg/m(2). Among 56 eligible patients with previously untreated, metastatic esophagogastric cancer enrolled in the phase II trial, three complete and 27 partial responses were observed (overall response rate=54%), and 15 patients (30%) had stable disease. Median progression-free survival was 7.1 months, and median survival was 11.9 months. At the final irinotecan dose of 50 mg/m(2), grade 3 or higher toxicity included diarrhea (26%), neutropenia (21%), nausea (18%), fatigue (16%), anorexia (13%), and thrombosis/embolism (13%).
  
  
  CONCLUSIONS
  Weekly TPC is an active and well-tolerated regimen for patients with esophagogastric cancer.
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA 02115, USA. peter_enzinger@dfci.harvard.edu
authors.forename: P C
authors.initials: PC
authors.lastname: Enzinger
authors.forename: D P
authors.initials: DP
authors.lastname: Ryan
authors.forename: J W
authors.initials: JW
authors.lastname: Clark
authors.forename: A
authors.initials: A
authors.lastname: Muzikansky
authors.forename: C C
authors.initials: CC
authors.lastname: Earle
authors.forename: M H
authors.initials: MH
authors.lastname: Kulke
authors.forename: J A
authors.initials: JA
authors.lastname: Meyerhardt
authors.forename: L S
authors.initials: LS
authors.lastname: Blaszkowsky
authors.forename: A X
authors.initials: AX
authors.lastname: Zhu
authors.forename: P
authors.initials: P
authors.lastname: Fidias
authors.forename: M M
authors.initials: MM
authors.lastname: Vincitore
authors.forename: R J
authors.initials: RJ
authors.lastname: Mayer
authors.forename: C S
authors.initials: CS
authors.lastname: Fuchs
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin