Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

Inclusion Criteria

• Histologically confirmed adenocarcinoma of the prostate
• Progressive metastatic disease or stable metastatic disease with rising PSA
• Previously treated with bilateral orchiectomy or other primary hormonal therapy with evidence of treatment failure
• Patients who have not undergone bilateral orchiectomy must continue luteinizing hormone-releasing hormone (LHRH)-agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist therapy (e.g. abarelix) while receiving study treatment
• Patients who did not have an orchiectomy must have a testosterone level = 40 mL/min
• Fertile patients must use effective contraception
• A taxane-based regimen, mitoxantrone, or other cytotoxic chemotherapy regimen allowed provided there is evidence of disease progression
• At least 4 weeks since prior chemotherapy or radiotherapy
• At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and there is continued evidence of disease progression
• Disease progression after antiandrogen withdrawal must be confirmed by rising PSA after the required 4-6 week washout period (e.g., PSA level higher than the last PSA obtained while on antiandrogen therapy)
• More than 4 weeks since prior estrogen, estrogen-like agents (e.g., PC-SPES, saw palmetto, or other herbal products that may contain phytoestrogens), or any other hormonal therapy (including megestrol, finasteride, ketoconazole, or systemic corticosteroids)
• Concurrent bisphosphonates (e.g., pamidronate sodium or zoledronate) allowed provided the patient has been receiving the bisphosphonate for >= 4 weeks and there is evidence of disease progression

Exclusion Criteria

• Active angina pectoris
• Known New York Heart Association class III-IV heart disease
• Myocardial infarction within the past 6 months
• Evidence of ventricular dysrhythmias or other unstable arrhythmia (rate-controlled atrial fibrillation is allowed if the patient is asymptomatic from a cardiac standpoint)
• Peripheral neuropathy > grade 2
• Other prior malignancy (excluding nonmelanomatous skin cancer treated with curative intent) unless the malignancy was treated with curative intent and the patient has been disease free for >= 5 years
• Serious concurrent medical illness or active infection that would preclude study treatment - No concurrent strong inhibitors or inducers of CYP3A4
• More than 2 prior chemotherapy regimens for hormone-refractory disease - Other concurrent investigational agents
• Other concurrent anticancer therapy, including chemotherapy, gene therapy, biologic therapy, or immunotherapy
• Concurrent palliative radiotherapy
• Concurrent estrogen, estrogen-like agents, or any other hormonal therapy
• Carcinomatous meningitis or brain metastases
• Prior strontium chloride Sr 89, samarium 153 lexidronam pentasodium, or other radioisotopes
• Concurrent therapeutic anticoagulation with warfarin (Unfractionated heparin [standard, low-dose, or adjusted dose] or low molecular weight heparin allowed