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 (i.e., new lesions on bone scan or new/enlarging lesions on CT scan) or stable metastatic disease*
• Patients with bone metastases only (i.e., lacking soft tissue disease) must have a prostate-specific antigen (PSA) level >= 5 ng/mL within the past 1 week
• Patients with soft tissue metastases and/or visceral disease must have either measurable disease OR a PSA level >= 5 ng/mL within the past 1 week
• Patients with stable metastases must have a rising PSA level within the past 4 weeks
• Two consecutive rises in PSA, each measurement taken >= 1 week apart
• [Note: *Radiologic evidence of hydronephrosis alone is not considered evidence of metastatic disease]

• Meets 1 of the following criteria:

  • Never received prior chemotherapy/cytotoxic therapy
  • Received prior taxane-based regimen
  • Received 2 prior cytotoxic chemotherapy regimens including, but not limited to, prior taxane and anthracyclines
• 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 < 50 ng/dL to confirm androgen suppression within the past 4 weeks
• ECOG performance status 0-2
• Granulocyte count >= 1,500/mm^3
• Platelet count >= 100,000/mm^3
• Bilirubin =< 1.5 mg/dL
• AST and ALT =< 2.5 times upper limit of normal
• Creatinine =< 2.0 mg/dL OR creatinine clearance >= 40 mL/min
• No active angina pectoris
• No known New York Heart Association class III-IV heart disease
• No myocardial infarction within the past 6 months
• No evidence of ventricular dysrhythmias or other unstable arrhythmia
• Rate-controlled atrial fibrillation is allowed if the patient is asymptomatic from a cardiac standpoint
• No peripheral neuropathy > grade 2
• No 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
• No serious concurrent medical illness or active infection that would preclude study treatment
• Fertile patients must use effective contraception
• No more than 2 prior chemotherapy regimens for hormone-refractory disease
• A taxane-based regimen, mitoxantrone, or other cytotoxic chemotherapy regimen allowed provided there is evidence of disease progression
• Treatment with estramustine is not considered a separate cytotoxic regimen
• 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 and no concurrent 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)
• No prior strontium chloride Sr 89, samarium 153 lexidronam pentasodium, or other radioisotopes
• No concurrent therapeutic anticoagulation with warfarin
• Unfractionated heparin (standard, low-dose, or adjusted dose) or low molecular weight heparin allowed
• 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
• No concurrent strong inhibitors or inducers of CYP3A4
• No other concurrent investigational agents
• No other concurrent anticancer therapy, including chemotherapy, gene therapy, biologic therapy, or immunotherapy
• No concurrent palliative radiotherapy
• No known carcinomatous meningitis or brain metastases