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

Inclusion 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