title: Gemcitabine plus celecoxib (GECO) in advanced pancreatic cancer: a phase II trial.
abstract: BACKGROUND
  Single agent gemcitabine (GEM) is the standard treatment of pancreatic adenocarcinoma. Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor. Recent studies in human pancreatic tumor cell lines suggest an involvement of COX-2 in tumor-dependent angiogenesis and provide the rational for inhibition of the COX pathway as an effective therapeutic approach. The aim of this study is to evaluate the toxicity and activity of gemcitabine plus celecoxib.
  
  
  METHODS
  Forty-two consecutive patients with histologically or cytologically confirmed pancreatic adenocarcinoma entered the trial. Twenty-six patients (pts) were metastatic, 16 pts had locally advanced disease. The schedule consisted of GEM 1,000 mg/m2 (as a 30 min iv infusion) on days 1, 8 every 3 weeks and celecoxib 400 mg bid.
  
  
  RESULTS
  Four pts (9%) achieved a partial response and 26 (62%) had stable disease, gaining a total disease control in 30 pts (71% [95% CI, 58-84%]). Overall clinical benefit response was experienced by 23 pts (54.7% [95%CI, 38.6-70.1%]). Neither grade 4 neutropenia nor grade 3-4 thrombocytopenia was observed. Grade 3 neutropenia was detected in 19% of pts. Grade 3 non-hematological toxicity was as follows: hepatic toxicity 7%, nausea 2.3%. Three pts (7%) and 5 pts (12%) had respectively a minimum creatinine increase and edema. Median survival was 9.1 months (95% CI, 7.5-10.6 months).
  
  
  CONCLUSIONS
  GEM in combination with celecoxib showed low toxicity, good clinical benefit rate and good disease control. Further clinical investigation is warranted.
authors.affiliation: U.O. Oncologia Medica, Beretta Foundation, Spedali Civili di Brescia, P.le Spedali Civili 1, 25123, Brescia, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Ferrari
authors.forename: Francesca
authors.initials: F
authors.lastname: Valcamonico
authors.forename: Vito
authors.initials: V
authors.lastname: Amoroso
authors.forename: Edda
authors.initials: E
authors.lastname: Simoncini
authors.forename: Lucia
authors.initials: L
authors.lastname: Vassalli
authors.forename: Patrizia
authors.initials: P
authors.lastname: Marpicati
authors.forename: Giovanni
authors.initials: G
authors.lastname: Rangoni
authors.forename: Salvatore
authors.initials: S
authors.lastname: Grisanti
authors.forename: Guido A M
authors.initials: GA
authors.lastname: Tiberio
authors.forename: Franco
authors.initials: F
authors.lastname: Nodari
authors.forename: Carla
authors.initials: C
authors.lastname: Strina
authors.forename: Giovanni
authors.initials: G
authors.lastname: Marini
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068579:Celecoxib; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011720:Pyrazoles / Q000008:administration & dosage; D013449:Sulfonamides / Q000008:administration & dosage; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D011720:Pyrazoles; D013449:Sulfonamides; D003841:Deoxycytidine; D000068579:Celecoxib; D000093542:Gemcitabine