Perifosine in Treating Patients With Metastatic, Androgen-Independent Prostate Cancer
RATIONALE: Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have prostate cancer that no longer responds to androgen ablation therapy.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial Of Oral Perifosine In Patients With Metastatic Androgen Independent Prostate Cancer|
|Study Start Date:||October 2003|
|Study Completion Date:||April 2004|
- Determine the 4-month progression-free survival rate, as measured by prostate-specific antigen and clinical criteria, in patients with metastatic androgen-independent prostate cancer treated with perifosine.
- Determine the side-effect profile of this drug in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
- Course 1: Patients receive oral perifosine twice on day 1 and once daily on days 2-21.
- All subsequent courses: Patients receive oral perifosine once daily on days 1-21.
In all courses, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within approximately 1.5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060437
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Edwin M. Posadas, MD||National Cancer Institute (NCI)|