Status:
COMPLETED
Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Prostate
Hormone-refractory Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the number of patients with a \> 50% decrease in prostate-specific antigen (PSA) of at least 4 weeks duration in patients with hormone-refractory metastatic prostate ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00337077
Start Date
November 1 2006
End Date
November 1 2013
Last Update
June 23 2014
Active Locations (147)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Community Hospital of Monterey Peninsula
Monterey, California, United States, 93940
3
Manchester Memorial Hospital
Manchester, Connecticut, United States, 06040
4
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486