A Phase II Study of GTI-2040 in Combination With Docetaxel and Prednisone in Hormone-Refractory Prostate Cancer

Fecha de inicio: 1 de enero de 2005

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