Ixabepilone Compared With Mitoxantrone and Prednisone in Treating Patients With Refractory Metastatic Prostate Cancer

You may be eligible if

• Histologically confirmed adenocarcinoma of the prostate
• Metastatic disease (positive bone scan or measurable disease)
• Progressive hormone-refractory disease
• * Based on 1 of the following:
• * Transaxial imaging
• * Rise in prostate-specific antigen (PSA)
• * Radionuclide bone scan
• * Must have undergone primary hormonal treatment (e.g., orchiectomy or gonadotropin-releasing hormone analog with or without an antiandrogen) and demonstrated disease progression after antiandrogen discontinuation as defined below:
• * Two consecutive rising PSA values, obtained at least 2 weeks apart, or documented osseous or soft tissue progression
• * For patients receiving flutamide, at least 1 PSA value must be obtained at least 4 weeks after flutamide discontinuation
• * For patients receiving bicalutamide or nilutamide, at least 1 PSA value must be obtained at least 6 weeks after antiandrogen discontinuation
• Meets 1 of the following criteria:
• * Measurable disease and an elevated PSA
• * Nonmeasurable disease and an elevated PSA, as follows:
• * Positive bone scan
• * PSA level at least 5 ng/mL, with increases on at least 2 successive occasions at least 2 weeks apart
• * New metastatic lesions by radionuclide bone scan
• Must have received at least 2 courses of paclitaxel- or docetaxel-based therapy, with disease progression documented during therapy or no more than 60 days after cessation of therapy\*
• Testosterone \< 50 ng/dL
• No known active brain metastases
• Performance status - ECOG 0-2
• At least 12 weeks
• Granulocyte count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Bilirubin \< 1.5 times upper limit of normal (ULN)
• AST and ALT \< 3 times ULN
• Creatinine ≤ 1.5 times ULN
• Creatinine clearance \> 40 mL/min
• Ejection fraction ≥ lower limit of normal by MUGA or echocardiogram
• No myocardial infarction within the past 6 months
• No significant cardiovascular disease
• No New York Heart Association class III or IV congestive heart failure
• No active angina pectoris
• Fertile patients must use effective contraception before, during, and for 3 months after study therapy
• No prior hypersensitivity reaction to agents containing Cremophor®EL
• No serious infection
• No nonmalignant medical illnesses that are uncontrolled or whose control would be jeopardized by complications of study therapy
• No psychiatric illness or social situation that would preclude study compliance
• No motor or sensory neuropathy grade 2 or greater
• No "currently active" second malignancy except nonmelanoma skin cancer
• * Patients are not considered to have a "currently active" malignancy provided they have completed therapy and are considered to have less than a 30% risk of relapse
• No concurrent prophylactic colony-stimulating factors for myelosuppression
• See Disease Characteristics
• No more than 1 prior chemotherapy regimen
• No prior mitoxantrone or epothilone
• No other concurrent chemotherapy
• See Disease Characteristics
• At least 4 weeks since prior antiandrogens (e.g., flutamide) (6 weeks for bicalutamide or nilutamide)
• * Patients must continue primary androgen deprivation therapy with luteinizing hormone-releasing hormone agonist during study if prior orchiectomy was not performed
• At least 4 weeks since prior systemic (including oral) corticosteroids except corticosteroids as part of first-line chemotherapy tapered off over 10-14 days prior to study entry
• At least 4 weeks since any prior hormonal therapy, including megestrol or finasteride
• No other concurrent systemic steroids
• At least 4 weeks since prior radiotherapy
• More than 8 weeks since prior radiopharmaceuticals (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
• No concurrent radiotherapy
• See Disease Characteristics
• At least 4 weeks since prior herbal products known to decrease PSA levels (e.g., Saw Palmetto or PC-SPES)
• More than 4 weeks since other prior antiprostate cancer therapy
• More than 4 weeks since prior systemic therapies for prostate cancer
• No other concurrent investigational agents