title: Multicenter phase-I/II study using a combination of gemcitabine and docetaxel in metastasized and unresectable, locally advanced pancreatic carcinoma.
abstract: OBJECTIVE
  To assess the maximum tolerability of a combined therapy regimen of gemcitabine and docetaxel, and to evaluate tumour response rate, survival time and tolerability in patients receiving these agents for advanced pancreatic carcinoma.
  
  
  METHODS
  Patients (n=68) with pancreatic carcinoma (advanced and/or unresectable tumour growth or histopathologically diagnosed metastases) were enrolled in a multicenter phase-I (n=25) and phase-II study (n=43). Treatment during phase II of the study was continued until either complete tumour remission (CR), tumour progression, indicated clinically or by means of radiological imaging, or until unacceptable toxicity occurred.
  
  
  RESULTS
  Phase I: the tolerability maximum of the combined agents was established at gemcitabine 1000 mg/m(2) and docetaxel 35 mg/m(2) with tolerable adverse events. Phase II: a total of 139 chemotherapy cycles were completed (mean, 3.2; range, 1-10). While CR was achieved in three of 43 patients (7%), in five further cases, partial remission (PR) was documented, amounting to an overall response rate (OR) of 18.6%. Eighteen patients showed stable disease (41.9%), whereas in 17 of 43 subjects (39.5%), primary tumour progression was detected. The median survival time was 9.0 months; the 1-year survival rate was 13.9% (six of 43 patients). These results were associated with a side-effect profile of moderate severity and acceptable quality of life (QOL).
  
  
  CONCLUSIONS
  The combination of gemcitabine and docetaxel for chemotherapy in unresectable pancreatic carcinoma was well tolerated. Survival time and 1-year survival rate proved promising and the regimen appears suitable for further evaluation in a prospective phase-III study setting.
authors.affiliation: Department of Surgery, University Hospital, Otto von Guericke University, Birkenallee 34, D-39130 Magdeburg, Germany. karsten.ridwelski@klinikum-magdeburg.de
authors.forename: K
authors.initials: K
authors.lastname: Ridwelski
authors.forename: J
authors.initials: J
authors.lastname: Fahlke
authors.forename: R
authors.initials: R
authors.lastname: Kuhn
authors.forename: A
authors.initials: A
authors.lastname: Hribaschek
authors.forename: E
authors.initials: E
authors.lastname: Kettner
authors.forename: C
authors.initials: C
authors.lastname: Greiner
authors.forename: A
authors.initials: A
authors.lastname: Florschuetz
authors.forename: T
authors.initials: T
authors.lastname: Manger
authors.forename: G
authors.initials: G
authors.lastname: Wilhelm
authors.forename: H
authors.initials: H
authors.lastname: Klein
authors.forename: S
authors.initials: S
authors.lastname: Hahnfeld
authors.forename: H
authors.initials: H
authors.lastname: Lippert
authors.forename: F
authors.initials: F
authors.lastname: Meyer
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077143:Docetaxel; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D012264:Ribonucleotide Reductases / Q000037:antagonists & inhibitors; D015996:Survival Rate; D043823:Taxoids / Q000627:therapeutic use*; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D012264:Ribonucleotide Reductases; D000093542:Gemcitabine