title: A phase II study of capecitabine plus docetaxel in gemcitabine-pretreated metastatic pancreatic cancer patients: CapTere.
abstract: OBJECTIVE
  Docetaxel and capecitabine combination is synergistic in preclinical models. We investigated the efficacy and toxicity of this combination as second-line chemotherapy in patients with metastatic pancreatic adenocarcinoma (mPC), pretreated with gemcitabine-based chemotherapy.
  
  
  METHODS
  Eligible patients were treated with capecitabine 800 mg/m(2) orally PO bid on days 1-14 in combination with intravenous docetaxel 30 mg/m(2) on days 1 and 8 of each 21-day cycle. The primary end point was overall response rate. Using a three-stage sequential design, two interim analyses for early stopping due to lack of efficacy were planned and conducted after 13 and 26 patients were accrued. Secondary end points included time to treatment failure, progression-free survival (PFS), overall survival (OS) and 50 % drop in CA19-9 levels.
  
  
  RESULTS
  Forty-three patients were evaluable for toxicity and 42 evaluable for response, at a median age of 64 years. The majority of patients (74 %) had ECOG PS 0-1. Six patients (14 %) achieved a partial tumor response, and stable disease for ≥2 cycles was observed in 59 % of patients (n = 25). Thirty-five percent (n = 11/31) of patients had a ≥50 % decrease in CA19-9 levels. The median PFS was 3.7 months (95 % CI 2.1-4.3 months), and the median OS was 5.3 months (95 % CI 4.3-8.6 months). Treatment was generally well tolerated. Grade 3 toxicity and grade 4 toxicity were seen in 45 and 5 % of patients, respectively. One patient had a potential treatment-related mortality.
  
  
  CONCLUSIONS
  The combination of capecitabine and docetaxel is active and well tolerated in mPC patients pretreated with gemcitabine-based therapy.
authors.affiliation: Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center, University of Miami, 1475 NW 12th Ave St 3300, Miami, FL, 33136, USA.
authors.forename: Heloisa P
authors.initials: HP
authors.lastname: Soares
authors.forename: Soley
authors.initials: S
authors.lastname: Bayraktar
authors.forename: Marcelo
authors.initials: M
authors.lastname: Blaya
authors.forename: Gilberto
authors.initials: G
authors.lastname: Lopes
authors.forename: Jaime
authors.initials: J
authors.lastname: Merchan
authors.forename: Jessica
authors.initials: J
authors.lastname: Macintyre
authors.forename: Carlos
authors.initials: C
authors.lastname: Mayo
authors.forename: Mark R
authors.initials: MR
authors.lastname: Green
authors.forename: Orlando
authors.initials: O
authors.lastname: Silva
authors.forename: Joe
authors.initials: J
authors.lastname: Levi
authors.forename: Gail
authors.initials: G
authors.lastname: Walker
authors.forename: Caio M
authors.initials: CM
authors.lastname: Rocha-Lima
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D000077143:Docetaxel; D004357:Drug Synergism; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine