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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

121

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2006

Longer than P75 for phase_2

Geographic Reach

1 country

147 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 years study duration

First Submitted

Initial submission to the registry

June 13, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2006

Completed

5 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed

4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed

8 months until next milestone

Results Posted

Study results publicly available

June 23, 2014

Completed

Last Updated

June 23, 2014

Status Verified

April 1, 2014

Enrollment Period

2.6 years

First QC Date

June 13, 2006

Results QC Date

February 14, 2014

Last Update Submit

May 21, 2014

Conditions

Adenocarcinoma of the Prostate Hormone-refractory Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer

Keywords

Eribulin Mesylatemetastatic hormone refractory prostate cancerHalichondrin B Analog

Outcome Measures

Primary Outcomes (1)

Proportion of Patients With PSA Response
PSA response is defined as a PSA decline from baseline value by \>=50%, or normalization of PSA (\<0.2 ng/ml) confirmed by a second measurement greater than or equal to 4 weeks later.
Assessed every 3 weeks during treatment; after off-treatment, every 3 months if patient is <2 years from study entry and every 6 months if patient is 2-5 years

Secondary Outcomes (1)

Proportion of Patients With Measurable Disease Response
Assessed every 9 weeks during treatment; after off-treatment, every 3 months if patient is <2 years from study entry and every 6 months if patient is 2-5 years from study entry

Study Arms (1)

Eribulin mesylate

EXPERIMENTAL

Patients receive eribulin mesylate IV over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: eribulin mesylate

Interventions

eribulin mesylateDRUG

Given IV

Also known as: B1939, E7389, ER-086526, halichrondrin B analog

Eribulin mesylate

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)
+2 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (147)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Community Hospital of Monterey Peninsula

Monterey, California, 93940, United States

Location

Manchester Memorial Hospital

Manchester, Connecticut, 06040, United States

Location

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Rush - Copley Medical Center

Aurora, Illinois, 60504, United States

Location

Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital Association

Canton, Illinois, 61520, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Mercy Hospital and Medical Center

Chicago, Illinois, 60616, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Sherman Hospital

Elgin, Illinois, 60123, United States

Location

Eureka Hospital

Eureka, Illinois, 61530, United States

Location

Evanston CCOP-NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare Galesburg

Galesburg, Illinois, 61401, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hopedale Medical Complex - Hospital

Hopedale, Illinois, 61747, United States

Location

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, 60435, United States

Location

Kewanee Hospital

Kewanee, Illinois, 61443, United States

Location

Mcdonough District Hospital

Macomb, Illinois, 61455, United States

Location

Garneau, Stewart C MD (UIA Investigator)