Conditions: Adenocarcinoma of the Prostate Hormone-refractory Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer
Keywords: Eribulin Mesylate metastatic hormone refractory prostate cancer Halichondrin B Analog
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 121
Healthy volunteers: no

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.

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 cancer treated with E7389 (eribulin mesylate).

SECONDARY OBJECTIVES:

I. Estimate the measurable disease response in patients with measurable disease.

II. Determine the duration of PSA and measurable disease response.

III. Characterize the safety and tolerability of E7389 in these patients.

OUTLINE:

This study enrolled 3 cohorts of patients based on the number of prior chemotherapy regimens received. The 3 cohorts are chemonaive stratum, prior-taxane stratum, and two-prior-chemotherapy stratum. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

Arms:
arm 1: 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.

Interventions: intervention 1: eribulin mesylate
Intervention descriptions: intervention 1: Given IV

Protocol document: