title: A Phase II study of gemcitabine and docetaxel in patients with metastatic pancreatic carcinoma.
abstract: BACKGROUND
  Patients with metastatic pancreatic carcinoma have a poor survival. Chemotherapy with gemcitabine is the standard first-line treatment. In a Phase II trial at one academic cancer center, the clinical safety and activity of combining gemcitabine and docetaxel were assessed.
  
  
  METHODS
  Patients with previously untreated, advanced pancreatic carcinoma were eligible. Bidimensionally measurable disease or evaluable disease with an elevated tumor marker, good performance status, and adequate organ function were required. Patients received docetaxel 60 mg/m(2) on Day 1 and gemcitabine 600 mg/m(2) on Days 1, 8, and 15 every 28 days. Ciprofloxacin was administered on Days 8-18. Dose attenuations were made as indicated for toxicity. Patients were restaged radiographically after every two cycles.
  
  
  RESULTS
  Thirty-four patients were enrolled, and 33 patients were evaluable for response. There were 23 men and 10 women among the evaluable patients. The median age was 63 years, and all patients had an Eastern Cooperative Oncology Group performance status of 0 or 1. Three patients had received prior chemoradiation for postresection adjuvant therapy. One hundred forty-six cycles of chemotherapy were administered, and 5 cycles (3%) in 4 patients (12%) were complicated by febrile neutropenia. Twenty percent and 11% of patients on Day 8 and Day 15 doses of gemcitabine, respectively, were omitted for toxicity. The objective response rate was 18%, and the median survival was 8.9 months (95% confidence interval, 5.2-11.2 months). The 1-year survival rate was 29%.
  
  
  CONCLUSIONS
  The combination of gemcitabine and docetaxel in patients with advanced pancreatic carcinoma is well tolerated and is associated with moderate activity despite aggressive dose reduction. Whether combination regimens are more effective than single agents in the treatment of patients with pancreatic carcinoma awaits evaluation in randomized studies.
authors.affiliation: Gastrointestinal Cancer Center, Dana-Farber/Partners Cancer Care, Boston, Massachusetts, USA. dpryan@partners.org
authors.forename: David P
authors.initials: DP
authors.lastname: Ryan
authors.forename: Matthew H
authors.initials: MH
authors.lastname: Kulke
authors.forename: Charles S
authors.initials: CS
authors.lastname: Fuchs
authors.forename: Michael L
authors.initials: ML
authors.lastname: Grossbard
authors.forename: Steven R
authors.initials: SR
authors.lastname: Grossman
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Morgan
authors.forename: Craig C
authors.initials: CC
authors.lastname: Earle
authors.forename: Ramesh
authors.initials: R
authors.lastname: Shivdasani
authors.forename: Haesook
authors.initials: H
authors.lastname: Kim
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Mayer
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Clark
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives*; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D043823:Taxoids; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D017239:Paclitaxel; D000093542:Gemcitabine