Ixabepilone in Treating Patients With Metastatic Prostate Cancer

Inclusion Criteria

• Histologically confirmed adenocarcinoma of the prostate
• Metastatic disease
• Evidence of disease progression (e.g., new lesions on bone scan or new/enlarging lesions on CT scan) OR rising prostate-specific antigen (PSA) within the past 4 weeks
• Radiologic evidence of hydronephrosis alone is not considered evidence of metastatic disease (e.g., increasing PSA)
• Patients with bone metastases only (i.e., lacking soft tissue disease) must have a PSA level >= 10 ng/mL within the past week
• Patients with stable disease and rising PSA must show 2 consecutive rises in PSA measurements taken at least 2 weeks apart
• Most recent PSA level must be obtained within the past 4 weeks
• Disease progression after prior anti-androgen withdrawal must be confirmed by a rising PSA after the 4-6 week washout period (e.g., PSA level higher than the last PSA obtained while on anti-androgen therapy)
• Failed prior bilateral orchiectomy or other primary hormonal therapy
• Patients who have not undergone bilateral orchiectomy must continue on luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist (e.g., abarelix) during study treatment AND must have a serum testosterone level = = 1,500/mm^3
• Platelet count >= 100,000/mm^3
• WBC >= 4,000/mm^3
• SGPT = = 50 mL/min
• No New York Heart Association class III-IV heart disease
• No myocardial infarction within the past 6 months
• No active angina pectoris
• No evidence of ventricular dysrhythmias or other unstable arrhythmia
• Rate-controlled atrial fibrillation allowed provided the patient is asymptomatic
• No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer
• No serious medical illness or active infection that would preclude study participation
• No concurrent prophylactic filgrastim (G-CSF)
• No more than 2 prior cytotoxic chemotherapy regimens for hormone-refractory disease
• At least 4 weeks since prior chemotherapy with a taxane-based regimen, mixantrone, or another cytotoxic chemotherapy regimen provided there is evidence of progressive disease
• At least 4 weeks since prior flutamide AND continued evidence of progressive disease
• At least 6 weeks since prior bicalutamide or nilutamide AND continued evidence of progressive disease
• At least 4 weeks since prior estrogen or estrogen-like agents (e.g., PC-SPES, saw palmetto, or other herbal products which may contain phytoestrogens)
• At least 4 weeks since prior hormonal therapy, including megestrol, finasteride, ketoconazole, or systemic corticosteroids
• No concurrent estrogen or estrogen-like agents (e.g., PC-SPES, saw palmetto, or other herbal products which may contain phytoestrogens)
• More than 4 weeks since prior radiotherapy
• No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
• No other prior radioisotope
• No concurrent radiotherapy for pain control
• No more than 1 prior experimental (non-cytotoxic) therapy AND evidence of progressive disease
• At least 4 weeks since prior experimental therapy
• Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed provided treatment was initiated at least 4 weeks ago and there is evidence of progressive disease
• No other concurrent investigational agents
• No concurrent therapeutic warfarin
• Concurrent prophylactic or therapeutic doses of low molecular weight heparin allowed provided criterion for INR is met
• No carcinomatous meningitis or brain metastases
• Fertile patients must use effective contraception
• No peripheral neuropathy > grade 1