Clinical trial NCT00337077 (phase 2, status: completed)
Conditions: adenocarcinoma of the prostate, hormone-refractory prostate cancer, recurrent prostate cancer, stage iv prostate cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: eribulin mesylate
SMILES: [H][C@@]12O[C@@]3([H])CCC4CC(=O)C[C@H]5[C@H](C[C@H]6O[C@H](C[C@@H](C)C6=C)CC[C@@H]6O[C@H](CC6=C)CC[C@@]67C[C@@H](O[C@H]1[C@@H](O6)[C@@]3([H])O4)[C@@H]2O7)O[C@H](C[C@H](O)CN)[C@@H]5OC
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