title: Docetaxel plus oblimersen sodium (Bcl-2 antisense oligonucleotide): an EORTC multicenter, randomized phase II study in patients with castration-resistant prostate cancer.
abstract: BACKGROUND
  This randomized, phase II study assessed the activity of oblimersen sodium, a Bcl-2 antisense oligonucleotide, administered before docetaxel (Taxotere) to patients with castration-resistant prostate cancer.
  
  
  METHODS
  Chemotherapy-naive patients with prostate-specific antigen (PSA) progression and testosterone < or = 0.5 ng/ml received docetaxel 75 mg/m2 on day 1 or oblimersen 7 mg/kg/day continuous i.v. infusion on days 1-7 with docetaxel 75 mg/m2 on day 5 every 3 weeks for < or = 12 cycles. Primary end points were confirmed PSA response (Bubley criteria) and major toxic events.
  
  
  RESULTS
  Confirmed PSA response was observed in 46% and 37% of 57 and 54 patients treated with docetaxel and docetaxel-oblimersen, respectively. Partial response (RECIST) was achieved in 18% and 24%, respectively. Oblimersen added to docetaxel was associated with an increase in the incidence of grade > or = 3 fatigue, mucositis, and thrombocytopenia. Major toxic events were reported in 22.8% and 40.7% of patients with docetaxel and docetaxel-oblimersen, respectively.
  
  
  CONCLUSIONS
  The primary end points of the study were not met: a rate of confirmed PSA response >30% and a major toxic event rate <45% were not observed with docetaxel-oblimersen.
authors.affiliation: Department of Medical Oncology, San Camillo and Forlanini Hospitals, Rome, Italy. cstern@mclink.it
authors.forename: C N
authors.initials: CN
authors.lastname: Sternberg
authors.forename: H
authors.initials: H
authors.lastname: Dumez
authors.forename: H
authors.initials: H
authors.lastname: Van Poppel
authors.forename: I
authors.initials: I
authors.lastname: Skoneczna
authors.forename: A
authors.initials: A
authors.lastname: Sella
authors.forename: G
authors.initials: G
authors.lastname: Daugaard
authors.forename: T
authors.initials: T
authors.lastname: Gil
authors.forename: J
authors.initials: J
authors.lastname: Graham
authors.forename: P
authors.initials: P
authors.lastname: Carpentier
authors.forename: F
authors.initials: F
authors.lastname: Calabro
authors.forename: L
authors.initials: L
authors.lastname: Collette
authors.forename: D
authors.initials: D
authors.lastname: Lacombe
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002369:Castration; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage; D013873:Thionucleotides / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D013873:Thionucleotides; D000077143:Docetaxel; C408162:oblimersen; D017430:Prostate-Specific Antigen