NCT00096499

SB-715992 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Docetaxel or Paclitaxel

A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Taxane-Resistant Androgen-Independent Metastatic Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Adenocarcinoma of the Prostate
• Recurrent Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	ispinesib	Given IV
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2005-04-01
• Primary completion: 2007-01-01
• First posted: 2004-11-10
• Last updated: 2013-01-25

Locations

1 site across 1 country: United States