SB-715992 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Docetaxel or Paclitaxel

Inclusion Criteria

• •Histologically confirmed adenocarcinoma of the prostate
• •* Metastatic disease (N1 and/or M1)
• •* Unresponsive or refractory to androgen-deprivation therapy
• •Must have received one, and only one, prior taxane-containing (docetaxel or paclitaxel) chemotherapy regimen for metastatic disease that was discontinued due to disease progression, intolerance, or patient request
• •Evidence of disease progression as defined by ≥ 1 of the following:
• •* Progression of measurable disease
• •* Progression of evaluable disease
• •* Rising prostate-specific antigen (PSA)
• •* At least 2 consecutive rises in PSA levels, each taken ≥ 7 days apart
• •* PSA ≥ 5 ng/mL
• •Must have pre-study PSA \> 5 ng/mL
• •Measurable or evaluable disease
• •* Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease
• •* Soft tissue disease that has been irradiated ≥ 2 months prior to study entry is considered measurable disease provided the lesion progressed after radiation
• •Surgical or medical castration required
• •* If luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or goserelin) or LHRH antagonists (abarelix) were used, then must continue use during study therapy
• •No prior or concurrent brain metastases (treated or untreated)
• •* If clinical suspicion of brain metastases, must meet the following criteria:
• •* Brain CT scan or MRI negative for metastatic disease within the past 56 days
• •* No new symptoms since radiographic evaluation
• •Performance status - Zubrod 0-2
• •Absolute granulocyte count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hemoglobin ≥ 9 g/dL
• •Bilirubin normal
• •SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
• •Creatinine ≤ 1.5 times ULN
• •Creatinine clearance ≥ 40 mL/min
• •No symptomatic congestive heart failure
• •No unstable angina pectoris
• •No cardiac arrhythmia
• •Fertile patients must use effective contraception
• •No peripheral neuropathy ≥ grade 2
• •No prior allergic reaction attributed to compounds of similar chemical or biological composition to SB-715992
• •No ongoing or active infection
• •No psychiatric illness or social situation that would preclude study participation
• •No other uncontrolled illness
• •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer in complete remission
• •No colony-stimulating factors during the first course of study therapy
• •No concurrent anticancer biologic therapy
• •See Disease Characteristics
• •At least 4 weeks since prior chemotherapy and recovered
• •See Disease Characteristics
• •At least 4 weeks since prior flutamide or ketoconazole
• •At least 6 weeks since prior bicalutamide or nilutamide
• •No concurrent anticancer hormonal therapy except LHRH agonist or antagonist for patients who have not undergone orchiectomy
• •See Disease Characteristics
• •At least 4 weeks since prior radiotherapy and recovered
• •Prior samarium Sm 153 lexidronam pentasodium allowed
• •No prior strontium chloride Sr 89
• •No prior radiotherapy to ≥ 30% of bone marrow
• •No concurrent anticancer radiotherapy
• •See Disease Characteristics
• •At least 3 weeks since prior surgery and recovered
• •At least 2 weeks since prior and no concurrent use of any of the following CYP3A4 inhibitors or inducers:
• •* Clarithromycin
• •* Erythromycin
• •* Troleandomycin
• •* Rifampin
• •* Rifabutin
• •* Rifapentine
• •* Itraconazole
• •* Ketoconazole
• •* Fluconazole (dose \> 200 mg/day)
• •* Voriconazole
• •* Nefazodone
• •* Fluvoxamine
• •* Verapamil
• •* Diltiazem
• •* Grapefruit juice
• •* Bitter orange
• •* Phenytoin
• •* Carbamazepine
• •* Phenobarbital
• •* Oxcarbazepine
• •* Hypericum perforatum (St. John's wort)
• •* Modafinil
• •At least 6 months since prior and no concurrent amiodarone
• •No other investigational drugs for 4 weeks before, during, and for 2 weeks after study therapy
• •No other concurrent anticancer cytotoxic therapy
• •No other concurrent anticancer therapy
• •No concurrent combination antiretroviral therapy for HIV-positive patients
• •Concurrent enrollment on SWOG-9205 (central prostate cancer serum repository protocol) allowed