Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Condition: Adenocarcinoma of the Prostate; Hormone-refractory Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: eribulin mesylate
Intervention description: Given IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Eribulin Mesylate; metastatic hormone refractory prostate cancer; Halichondrin B Analog

Summary:

      This phase II trial is studying how well eribulin mesylate (E7389; Halichondrin B Analog)
      works in treating patients with metastatic prostate cancer that did not respond to hormone
      therapy. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to
      stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing.
    

Eligibility criteria:

        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 < 50 ng/dL to
             confirm androgen suppression within the past 4 weeks

          -  ECOG performance status 0-2

          -  Adequate bone marrow function

          -  Bilirubin =< 1.5 mg/dL

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper
             limit of normal

          -  Creatinine =< 2.0 mg/dL OR creatinine clearance >= 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