title: Docetaxel plus gemcitabine in combination with capecitabine as treatment for inoperable pancreatic cancer: a phase II study.
abstract: OBJECTIVE
  To evaluate the activity and tolerance of gemcitabine in combination with docetaxel and capecitabine in previously untreated patients with advanced pancreatic cancer.
  
  
  METHODS
  Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were treated with gemcitabine (1,500 mg/m(2) on days 1 and 15), docetaxel (50 mg/m(2) on days 1 and 15) and capecitabine (2,250 mg/m(2), orally in two daily divided doses, on days 1-7 and 15-21). All three drugs were administered in 4-week cycles, in an initial prospective plan of six cycles. The primary end-point was response rate.
  
  
  RESULTS
  Forty patients were enrolled in the study. At the time of enrollment, 40% of patients had locally advanced and 60% metastatic disease. All patients were evaluable for response and toxicity. On an intent-to-treat analysis, the overall response and disease control rates were 40 and 80%, respectively. The median progression-free survival was 6.0 months, and the median overall survival was 9.0 months. Major grade 3/4 toxicities were neutropenia (17.5%), diarrhea (10%) and hand-foot syndrome (7.5%). There was no treatment-related death.
  
  
  CONCLUSIONS
  The combination of gemcitabine with docetaxel and capecitabine is feasible and exhibits satisfactory degree of activity in patients with advanced pancreatic cancer, deserving further exploration.
authors.affiliation: Department of Medical Oncology, University General Hospital of Alexandroupolis, Dragana, 68100 Alexandroupolis, Thrace, Greece.
authors.forename: N
authors.initials: N
authors.lastname: Xenidis
authors.forename: L
authors.initials: L
authors.lastname: Chelis
authors.forename: K
authors.initials: K
authors.lastname: Amarantidis
authors.forename: E
authors.initials: E
authors.lastname: Chamalidou
authors.forename: P
authors.initials: P
authors.lastname: Dimopoulos
authors.forename: N
authors.initials: N
authors.lastname: Courcoutsakis
authors.forename: A
authors.initials: A
authors.lastname: Tentes
authors.forename: A
authors.initials: A
authors.lastname: Chiotis
authors.forename: P
authors.initials: P
authors.lastname: Prassopoulos
authors.forename: S
authors.initials: S
authors.lastname: Kakolyris
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000855:Anorexia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D060831:Hand-Foot Syndrome / Q000209:etiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine