This is a multi-centre, phase II, open-label, two-stage design, single-arm study in patients with hormone-refractory prostate cancer (HRPC) with advanced (rising PSA) and/or metastatic disease and who have had prior anti-androgen therapy. The study will further explore the efficacy of E7389 by enrollment of patients into two strata: those who have had no prior systemic chemotherapy for their disease (except for mitoxantrone and estramustine), and those who failed no more than one previous chemotherapeutic regimen with tubulin-binding agents such as docetaxel.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Intravenous 1.4 mg/m2 on a 3-week course.
Dr. Robert Jotte
Denver, Colorado, United States
Melbourne Internal Medicine Associates
Melbourne, Florida, United States
Ocala Oncology Center PL
Ocala, Florida, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, United States
Minnesota Hematology Oncology
Burnsville, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
St. Luke's Roosevelt Hospital Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Raleigh Hematology Oncology Associates PL
Raleigh, North Carolina, United States
...and 8 more locations
Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria
Bubley Criteria: Patients must have progressive disease to enter study. For outcomes, PSA response must show at least 50% decrease. Duration of response is the time from \>50% decrease from baseline to when there is a 50% decrease in nadir. PSA progressive disease- 25% increase from baseline or increase of 5 ng/mL along with measureable disease Stable disease- decline of less than 50% and not more than 25% increase.
Time frame: 12 months
Duration of Prostate Specific Antigen Response Based on Bubley Criteria
Duration of response is the time from \>50% decrease from baseline to when there is a 50% decrease in nadir.
Time frame: 12 months.
Progression Free Survival
From the date study treatment was initiated until the earliest date of the first PSA assessment that determined progressive disease, or the death of death if death occurred without disease progression.
Time frame: 12 months
Overall Survival
Time frame: 12 months
Best Objective Tumor Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).
Time frame: 12 months
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