title: Phase II trial of docetaxel/capecitabine in hormone-refractory prostate cancer.
abstract: BACKGROUND
  Docetaxel is the most active single agent in the treatment of hormone-refractory prostate cancer (HRPC). Because of the preclinical and clinical evidence of synergy of capecitabine and docetaxel, it was hypothesized that this combination would be active and tolerable in HRPC.
  
  
  METHODS
  Patients received docetaxel 60 mg/m2 intravenously over 60 minutes on day 1 of each 21-day cycle and capecitabine 1000 mg/m2 administered orally twice daily on days 1-14 of each cycle for a maximum of 8 cycles or until disease progression or intolerable toxicity. Seventy-seven patients were enrolled at 43 US Oncology sites. The median age was 69.3 years (range, 48-86 years); 86% were white, and the Eastern Cooperative Oncology Group performance status scores of 0 and 1 were 49% and 51% respectively. Sixty-nine (90%) patients were evaluated for prostate-specific antigen response.
  
  
  RESULTS
  Overall, 41% of patients had a decreased prostate specific antigen level > or = 50%. There were 4 complete responses (6%), 24 partial responses (35%), 29 incidences of stable disease (43%), and 11 incidences of progressive disease (16%). Nine patients has stable disease > or = 6 months and the clinical benefit rate was 54%. The median time to response was 1.5 months (range, 1-16.9 months). The estimated survival at 12 and 24 months (range, < 1-27 months). There were no treatment-related deaths. Grade 3/4 toxicities included neutropenia (50%), leukopenia (22%), hand-foot syndrome (17%), fatigue (11%), and nausea (11%).
  
  
  CONCLUSIONS
  Docetaxel/capcitabine is an active and tolerable combination in HRPC. Toxicity was acceptable and anticipated. Response rate and survival are comparable with other docetaxel combinations.
authors.affiliation: US Oncology Research Inc, Houston, TX, USA. michael.kolodziej@usoncology.com
authors.forename: Michael
authors.initials: M
authors.lastname: Kolodziej
authors.forename: Marcus A
authors.initials: MA
authors.lastname: Neubauer
authors.forename: Steven R
authors.initials: SR
authors.lastname: Rousey
authors.forename: Robert E
authors.initials: RE
authors.lastname: Pluenneke
authors.forename: George
authors.initials: G
authors.lastname: Perrine
authors.forename: Stephanie
authors.initials: S
authors.lastname: Mull
authors.forename: Kristi A
authors.initials: KA
authors.lastname: Boehm
authors.forename: Des
authors.initials: D
authors.lastname: Ilegbodu
authors.forename: Lina
authors.initials: L
authors.lastname: Asmar
mesh_terms: D000230:Adenocarcinoma / Q000175:diagnosis / Q000188:drug therapy*; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009376:Neoplasms, Hormone-Dependent / Q000175:diagnosis / Q000188:drug therapy*; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000175:diagnosis / Q000188:drug therapy*; D011788:Quality of Life; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D017430:Prostate-Specific Antigen; D005472:Fluorouracil