Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
This phase II trial is studying how well eribulin mesylate 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.
Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Drug: eribulin mesylate
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of E7389 (Halichondrin B Analog), in Patients With Metastatic Hormone Refractory Prostate Cancer|
- Number of patients with a greater than or equal to 50% decrease in Prostate-specific antigen (PSA) levels [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
- Measurable disease response assessed by Response Evaluation Criteria for Solid Tumors (RECIST) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Overall response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: From the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease is objectively documented, up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: Treatment (eribulin mesylate)
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
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).
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.
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.