Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060437
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2003-05-06
Brief Title:
Perifosine in Treating Patients With Metastatic Androgen-Independent Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial Of Oral Perifosine In Patients With Metastatic Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2004-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 15 years
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 15 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-5970 | None | None | None |
| NCI-03-C-0157 | None | None | None |