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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Given IV
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Community Hospital of Monterey Peninsula
Monterey, California, United States
Manchester Memorial Hospital
Manchester, Connecticut, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
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.
Time frame: 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
Proportion of Patients With Measurable Disease Response
Measurable disease response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Measurable disease response = CR + PR. Only patients with measurable disease at baseline are included in this analysis.
Time frame: 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
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Rush - Copley Medical Center
Aurora, Illinois, United States
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Bloomington, Illinois, United States
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Carthage, Illinois, United States
Mercy Hospital and Medical Center
Chicago, Illinois, United States
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