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

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer
Eligibility 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
Sites / Locations
- British Columbia Cancer Agency - Vancouver Cancer Centre
- Margaret and Charles Juravinski Cancer Centre
- London Regional Cancer Program at London Health Sciences Centre
- Ottawa Hospital Regional Cancer Centre - General Campus
- Princess Margaret Hospital