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A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Taxane-Resistant Androgen-Independent Metastatic Prostate Cancer
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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Southwest Oncology Group
San Antonio, Texas, United States
Start Date
April 1, 2005
Primary Completion Date
January 1, 2007
Last Updated
January 25, 2013
40
ACTUAL participants
ispinesib
DRUG
pharmacological study
OTHER
laboratory biomarker analysis
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT05691465
NCT04550494
Data Source & Attribution
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