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

Inclusion Criteria

• •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