Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058214
Status:
TERMINATED
Last Update Posted:
2015-02-23
First Post:
2003-04-07
Brief Title:
Perifosine in Treating Patients With Recurrent Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Perifosine IND 58156 NSC 639966 in Biochemically Recurrent Hormone Sensitive Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Did not meet interim stopping criteria for continuation to the second stage
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase II trial to study the effectiveness of perifosine in treating patients who have recurrent prostate cancer Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To assess the PSA response in prostate cancer patients with only biochemical recurrence after local curative therapy who are then treated with perifosine
II To assess the secondary endpoints of a six-month increase in PSA levels compared to baseline b PSA doubling time and c time to PSA progression in prostate cancer patients receiving perifosine
III To evaluate the qualitative and quantitative toxicities of this agent in this patient population
IV To investigate potential molecular markers predictive of decreased PSADT and possibly PSA response in prostate cancer patients receiving perifosine
OUTLINE This is a multicenter study Patients are stratified according to prior therapy surgery vs radiotherapy with or without brachytherapy vs surgery and radiotherapy and original combined Gleason score 7 or less vs 8-10
Patients receive oral perifosine once daily on days 1-28 On day 1 of course 1 only patients receive 2 doses of oral perifosine Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression
I To assess the PSA response in prostate cancer patients with only biochemical recurrence after local curative therapy who are then treated with perifosine
II To assess the secondary endpoints of a six-month increase in PSA levels compared to baseline b PSA doubling time and c time to PSA progression in prostate cancer patients receiving perifosine
III To evaluate the qualitative and quantitative toxicities of this agent in this patient population
IV To investigate potential molecular markers predictive of decreased PSADT and possibly PSA response in prostate cancer patients receiving perifosine
OUTLINE This is a multicenter study Patients are stratified according to prior therapy surgery vs radiotherapy with or without brachytherapy vs surgery and radiotherapy and original combined Gleason score 7 or less vs 8-10
Patients receive oral perifosine once daily on days 1-28 On day 1 of course 1 only patients receive 2 doses of oral perifosine Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHII-44 | None | None | None |
| CDR0000287195 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17101 |
| N01CM17101 | NIH | None | None |