Docetaxel With or Without Oblimersen in Treating Patients With Hormone-Refractory Adenocarcinoma (Cancer) of the Prostate
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Hormone-refractory disease Disease progression after prior hormonal therapy with luteinizing hormone-releasing hormone (LH-RH) analogues or orchiectomy and antiandrogens (given together or consecutively) Prostate-specific antigen (PSA) progression documented by at least 2 increases in PSA values over previous PSA reference value Must demonstrate continued PSA elevation for at least 6 weeks after discontinuation of antiandrogen therapy PSA ≥ 5 ng/mL (Hybritech or equivalent) within the past week Testosterone ≤ 0.5 ng/mL* NOTE: *Patients with medical castration with LH-RH analogue must continue with LH-RH analogue throughout the study No evidence of painful and/or destructive bone metastases requiring concurrent radiotherapy, bisphosphonates, or bone-seeking radionuclides Other bone metastases allowed No clinical evidence of brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 WBC ≥ 3,500/mm^3 Hemoglobin ≥ 10 g/dL Hepatic AST and ALT ≤ 1.5 times upper limit of normal (ULN) Bilirubin ≤ ULN PTT and PT ≤ 1.5 times ULN OR INR ≤ 1.3 Renal Creatinine ≤ 1.5 times ULN OR Creatinine clearance ≥ 50 mL/min Cardiovascular No unstable angina No uncontrolled hypertension No deep venous thrombosis within the past 6 months No cerebrovascular accident, transient ischemic attack, or myocardial infarction within the past 6 months Pulmonary No pulmonary embolism No history of interstitial pneumonitis No history of pulmonary fibrosis Other Adequate venous access HIV negative No active infection No pre-existing neuropathy No hypersensitivity to phosphorothioates No hypersensitivity to oligonucleotides or any other component of the oblimersen formulation or to drugs formulated with polysorbate No psychological, familial, sociological, or geographical condition that would preclude study compliance No other malignancy within the past 5 years except adequately treated superficial urothelial or skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Prior estramustine allowed No other prior chemotherapy No concurrent estramustine Endocrine therapy See Disease Characteristics At least 6 weeks since prior flutamide, bicalutamide, or nilutamide More than 6 weeks since prior hormonal manipulation with PC-SPES Concurrent LH-RH agonist allowed No concurrent antiandrogens Radiotherapy See Disease Characteristics No prior radiotherapy involving > 25% of marrow-producing area No prior bone-seeking radionuclides No concurrent radiotherapy (including palliative therapy for painful bone metastases) No concurrent bone-seeking radionuclides Surgery See Disease Characteristics Other Prior bisphosphonates allowed No concurrent anticoagulation except for low-dose warfarin (1 mg/day) No concurrent regular (daily) intake of opioid analgesics No other concurrent experimental drugs or anticancer drugs No concurrent bisphosphonates
Sites / Locations
- Kaiser Franz Josef Hospital
- Onze Lieve Vrouw Ziekenhuis Aalst
- Institut Jules Bordet
- Cliniques Universitaires Saint-Luc
- Universitair Ziekenhuis Gent
- U.Z. Gasthuisberg
- Rigshospitalet - Copenhagen University Hospital
- CHU de Grenoble - Hopital de la Tronche
- Assaf Harofeh Medical Center
- Ospedale S. Camillo-Forlanini
- Academisch Medisch Centrum at University of Amsterdam
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
- Hospital Desterro
- Hospital General Universitari Vall d'Hebron
- Saint Bartholomew's Hospital
- Western Infirmary