Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080899
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2004-04-07
Brief Title:
Fenretinide in Treating Patients With Biochemically Recurrent Hormone-Naïve Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Fenretinide 4-HPR in Biochemically Recurrent Hormone Naive Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
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:
This phase II trial is studying how well fenretinide works in treating patients with biochemically rising PSA level recurrent hormone-naïve no previous hormone therapy prostate cancer Drugs used in chemotherapy such as fenretinide work in 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 fenretinide 4-HPR
II To assess PSA doubling time as a measure of disease activity time to PSA progression in prostate cancer patients receiving fenretinide
III To evaluate the qualitative and quantitative toxicities of this agent in this patient population
IV To evaluate pharmacokinetic studies on the bioavailability of 4-HPR in this patient population
OUTLINE This is a multicenter study Patients are stratified according to prior therapy surgery vs radiotherapy andor brachytherapy vs both stage at diagnosis organ confined vs extra-capsular extension vs lymph node positive Gleason score at diagnosis 2-4 vs 5-6 vs 7-10 and prostate-specific antigen level at diagnosis 0-4 ngmL vs 41-10 ngmL vs 10 ngmL
Patients receive oral fenretinide twice daily on days 1-7 Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity
I To assess the PSA response in prostate cancer patients with only biochemical recurrence after local curative therapy who are then treated with fenretinide 4-HPR
II To assess PSA doubling time as a measure of disease activity time to PSA progression in prostate cancer patients receiving fenretinide
III To evaluate the qualitative and quantitative toxicities of this agent in this patient population
IV To evaluate pharmacokinetic studies on the bioavailability of 4-HPR in this patient population
OUTLINE This is a multicenter study Patients are stratified according to prior therapy surgery vs radiotherapy andor brachytherapy vs both stage at diagnosis organ confined vs extra-capsular extension vs lymph node positive Gleason score at diagnosis 2-4 vs 5-6 vs 7-10 and prostate-specific antigen level at diagnosis 0-4 ngmL vs 41-10 ngmL vs 10 ngmL
Patients receive oral fenretinide twice daily on days 1-7 Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| CDR0000357312 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62209 |
| PHII-47 | None | None | None |
| N01CM62209 | NIH | None | None |