GTI-2040, Docetaxel, and Prednisone in Treating Patients With Prostate Cancer

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:
• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Metastatic carcinoma of presumptive prostate origin
• Bony metastases AND a serum prostate-specific antigen (PSA) level > 20 ng/mL
• Disease progression after prior hormonal therapy as defined by rising PSA levels
• At least 2 consecutive rises in PSA over a reference value, with measurements taken at least 7 days apart
• Prior hormonal therapy must include either medical (luteinizing hormone-releasing hormone [LHRH] agonist) OR surgical (orchiectomy) castration
• Patients who received prior LHRH agonist must continue or re-start such therapy
• Castrate levels of testosterone < 50 ng/dL
• PSA ≥ 20 ng/mL
• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR
• Karnofsky 60-100%

Life expectancy

• More than 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• WBC ≥ 3,000/mm^3

Hepatic

• AST and ALT ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin normal
• PTT ≤ 1.25 times upper limit of control
• INR ≤ 1.3

Renal

• Creatinine ≤ 1.5 times ULN OR
• Creatinine clearance ≥ 50 mL/min

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• Fertile patients must use effective contraception
• No symptomatic peripheral neuropathy ≥ grade 2
• No history of allergic reaction attributed to compounds of similar chemical or biologic composition to GTI-2040 or other study agents
• No concurrent uncontrolled illness
• No active or ongoing infection
• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent prophylactic filgrastim (G-CSF) or epoetin alfa

Chemotherapy

• No prior chemotherapy except monotherapy with oral estramustine
• At least 4 weeks since prior estramustine and recovered

Endocrine therapy

• See Disease Characteristics
• At least 6 weeks since prior bicalutamide*
• At least 4 weeks since prior flutamide, nilutamide, or cyproterone*
• Concurrent steroids allowed NOTE: *Patients must have evidence of disease progression despite cessation of antiandrogen therapy

Radiotherapy

• At least 4 weeks since prior radiotherapy
• No prior radiotherapy to > 25% of bone marrow
• No prior isotope therapy

Surgery

• See Disease Characteristics

Other

• No concurrent prophylactic antibiotics
• No concurrent anticoagulants
• Concurrent low-dose warfarin for prophylaxis of central line thrombosis allowed
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents or therapies