title: Capecitabine and celecoxib as second-line treatment of advanced pancreatic and biliary tract cancers.
abstract: OBJECTIVE
  An increasing number of patients with advanced pancreatic or biliary tract cancer who progress after a gemcitabine-containing regimen are candidates for further chemotherapy. We therefore evaluated a fully oral regimen of capecitabine and celecoxib (CapCel) as second-line treatment in these patients.
  
  
  METHODS
  Thirty-five patients with documented progressive disease after first-line treatment were enrolled. Capecitabine was administered at a dose of 1,000 mg/m(2) b.i.d. for 2 consecutive weeks followed by 1 week of rest; celecoxib was given continuously at 200 mg b.i.d. Progression-free survival at 3 months was the primary study endpoint.
  
  
  RESULTS
  The CapCel combination was associated with an overall response rate of 9% and median survival duration of 19 weeks. Sixty percent of patients were free from progression 3 months after the start of treatment. Multivariate analysis identified a positive clinical benefit response and a decline in CA 19.9 serum levels >25% compared with baseline levels as independent predictors of prolonged survival. The treatment protocol was well tolerated with negligible hematological toxicity. The most common grade 3 non-hematological toxicities were hypertransaminasemia, diarrhea and asthenia.
  
  
  CONCLUSIONS
  The CapCel combination is a safe treatment option with moderate activity in patients with pancreatic/biliary tract cancer after failure of a previous gemcitabine-containing regimen.
authors.affiliation: Department of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Maria S
authors.initials: MS
authors.lastname: Pino
authors.forename: Michele
authors.initials: M
authors.lastname: Milella
authors.forename: Alain
authors.initials: A
authors.lastname: Gelibter
authors.forename: Isabella
authors.initials: I
authors.lastname: Sperduti
authors.forename: Salvatore
authors.initials: S
authors.lastname: De Marco
authors.forename: Carmen
authors.initials: C
authors.lastname: Nuzzo
authors.forename: Emilio
authors.initials: E
authors.lastname: Bria
authors.forename: Livio
authors.initials: L
authors.lastname: Carpanese
authors.forename: Enzo M
authors.initials: EM
authors.lastname: Ruggeri
authors.forename: Paolo
authors.initials: P
authors.lastname: Carlini
authors.forename: Francesco
authors.initials: F
authors.lastname: Cognetti
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000401:mortality; D000069287:Capecitabine; D021441:Carcinoma, Pancreatic Ductal / Q000188:drug therapy* / Q000401:mortality; D000068579:Celecoxib; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D011446:Prospective Studies; D011720:Pyrazoles / Q000008:administration & dosage* / Q000009:adverse effects; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D011720:Pyrazoles; D013449:Sulfonamides; D003841:Deoxycytidine; D000069287:Capecitabine; D000068579:Celecoxib; D005472:Fluorouracil