Atrasentan in Treating Patients With Prostate Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase III trial to determine the effectiveness of atrasentan in treating patients who have prostate cancer that has not responded to hormone therapy.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III Extension Study to Evaluate the Safety of 10 mg Atrasentan in Men With Hormone-Refractory Prostate Cancer|
|Study Start Date:||September 2002|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
- Determine the safety of atrasentan in patients with hormone-refractory prostate cancer.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral atrasentan once daily for 3 years in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month and then every 3 months for 2 years.
PROJECTED ACCRUAL: Approximately 1,400 patients will be accrued for this study.