title: Phase I/II study on docetaxel, gemcitabine and prednisone in castrate refractory metastatic prostate cancer.
abstract: OBJECTIVE
  We assessed the efficacy and toxicity of a fixed dose of docetaxel and prednisone, combined with escalating doses of gemcitabine (DGP). The primary endpoint was PSA response.
  
  
  METHODS
  Fifteen patients were enrolled in the phase I and 50 patients entered the phase II. Patients were given DGP, maximum of eight courses, until progression or unacceptable toxicity. Docetaxel 75 mg/m(2) was administered intravenously day 1, gemcitabine was given day 1 and 8 in doses increasing from 600 to 1,000 mg/m(2) every third week. Patients had castrate refractory metastatic prostate cancer (CRMPC), adequate function of liver, kidney and bone marrow; ECOG performance status <or=2 and were chemotherapy-naïve.
  
  
  RESULTS
  Median age was 64 range (49-77). Twenty-one (42%) were PS 0, 26 (52%) were PS 1 and 3 (6%) were PS 2. The median pre-treatment PSA was 448 (12-4.580). No dose limiting toxicity was observed even with the highest dose level in the phase I part of the study. In the phase II part, PSA response was observed in 37 (74%) patients. Twenty-four (48%) patients had measurable disease; 12 (50%) had partial remission, 5 (21%) had stable disease, 7 (29%) were not evaluable. Time to progression (TTP) was 7.9 months and overall survival (OS) was 13.9 months. Thirty-seven patients (74%) developed neutropenia, non-haematological toxicity was modest.
  
  
  CONCLUSIONS
  The PSA response rate was promising and the toxicity of DGP was manageable; however OS was comparable to results of treatment with single agent docetaxel.
authors.affiliation: Department of Oncology, Herlev University Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark. trzebu01@heh.regionh.dk
authors.forename: Trine Zeeberg
authors.initials: TZ
authors.lastname: Buch-Hansen
authors.forename: Lise
authors.initials: L
authors.lastname: Bentzen
authors.forename: Steinbjoern
authors.initials: S
authors.lastname: Hansen
authors.forename: Morten
authors.initials: M
authors.lastname: Hoeyer
authors.forename: Niels Viggo
authors.initials: NV
authors.lastname: Jensen
authors.forename: Charlotte
authors.initials: C
authors.lastname: Saxe
authors.forename: Lisa
authors.initials: L
authors.lastname: Sengeloev
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D023381:Endpoint Determination; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009919:Orchiectomy; D010146:Pain / Q000453:epidemiology / Q000209:etiology; D010166:Palliative Care; D011241:Prednisone / Q000008:administration & dosage; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D000093542:Gemcitabine
chemical_list: D000893:Anti-Inflammatory Agents; D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D011241:Prednisone; D000093542:Gemcitabine