Spots Global Cancer Trial Database for Perifosine in Treating Patients With Metastatic, Androgen-Independent Prostate Cancer

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Trial Identification

Brief Title: Perifosine in Treating Patients With Metastatic, Androgen-Independent Prostate Cancer

Official Title: A Phase II Trial Of Oral Perifosine In Patients With Metastatic Androgen Independent Prostate Cancer

Study ID: NCT00060437

Conditions

Prostate Cancer

Interventions

perifosine

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: * 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. OUTLINE: * 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.