Docetaxel and Prednisone With/Out OGX-011 in Recurrent or Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Metastatic or locally recurrent disease
• Not curable with standard therapy
• Systemic chemotherapy is indicated, due to disease progression while receiving androgen-ablative therapy (i.e., hormone-refractory disease)
• Disease progression is defined as development of new metastatic lesions OR ≥ 2 consecutive rises in prostate-specific antigen (PSA) over a reference value
• Androgen ablative therapy must have included either medical or surgical castration
• Castrate level of testosterone (≤ 1.7 nmol/L) required if treated with medical androgen ablation
• Patients with documented disease progression while on peripheral antiandrogens must also have documented PSA progression after stopping antiandrogens
• PSA ≥ 5 ng/mL
• No known CNS metastases

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• No known bleeding disorder

Hepatic

• PT and PTT or INR normal
• Bilirubin normal
• AST and ALT ≤ 1.5 times upper limit of normal (ULN)

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No significant cardiac dysfunction

Other

• Fertile patients must use effective contraception
• No pre-existing peripheral neuropathy ≥ grade 2
• No active, uncontrolled infection
• No significant neurological disorder that would preclude study compliance
• No history of other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Chemotherapy

• No prior chemotherapy except estramustine and recovered
• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics
• At least 4 weeks since prior antiandrogens (6 weeks for bicalutamide)
• Luteinizing hormone-releasing hormone (LHRH) agonist therapy must be continued* or restarted* during study treatment to maintain castrate levels of testosterone NOTE: *For patients receiving LHRH agonist therapy prior to study entry

Radiotherapy

• At least 4 weeks since prior external beam radiotherapy except low-dose, nonmyelosuppressive radiotherapy
• Must have had less than 25% of marrow irradiated
• No prior strontium chloride Sr 89
• No concurrent radiotherapy except low-dose, nonmyelosuppressive, palliative radiotherapy

Surgery

• At least 2 weeks since prior major surgery

Other

• At least 4 weeks since prior investigational agent
• At least 4 weeks since prior anticancer therapy
• No concurrent therapeutic anticoagulants except low-dose oral anticoagulants (i.e., 1 mg warfarin) or low molecular weight heparin
• No other concurrent investigational agents
• No other concurrent cytotoxic therapy