Adenocarcinoma of the Prostate Clinical Trial
Official title:
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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