Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well SB-715992 works in treating patients with metastatic prostate cancer that did not respond to docetaxel or paclitaxel
PRIMARY OBJECTIVES: I. Determine the prostate-specific antigen response to SB-715992 in patients with hormone-refractory, androgen-independent metastatic prostate cancer that failed prior taxane-based chemotherapy. SECONDARY OBJECTIVES: I. Determine the median overall survival and median progression-free survival of patients treated with this drug. II. Determine the objective response rate (confirmed and unconfirmed, complete and partial response) in patients with measurable disease treated with this drug. III. Determine the qualitative and quantitative toxic effects of this drug in these patients. IV. Determine, preliminarily, the pharmacokinetics and mechanism of activity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 1.3-2.7 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Southwest Oncology Group
San Antonio, Texas, United States
Probability of PSA response
Time frame: Up to 3 years
Overall survival
Time frame: From date of registration to date of death due to any cause, assessed up to 3 years
Progression-free survival
Time frame: From date of registration to date of first observation of progressive disease, symptomatic deterioration, or death due to any cause, assessed up to 3 years
Probability of objective response
Time frame: Up to 3 years
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