Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480623
Status:
TERMINATED
Last Update Posted:
2012-03-23
First Post:
2007-05-29
Brief Title:
A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence
Sponsor:
Agennix
Organization:
Agennix
Study Overview
Official Title:
A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence Following Radical Prostatectomy
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decided to discontinue study drug development
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to measure the impact of Satraplatin plus radiation therapy to the bed of the prostate in patients who have developed biochemical failure of their prostate cancer The main objective of this study is to determine the maximum tolerated dose and dose limiting toxicity for the combination of satraplatin and radiation therapy and to determine the recommended dose for subsequent Phase II trials
Detailed Description:
Please Note DrHoward Sandlers site will be open to accrual shortly Dr Sarantopouloss site in San Antonio is open and recruiting patients
There were approximately 232000 cases of prostate cancer diagnosed in the US in 2005 Most patients present with localized disease and undergo curative therapy either radical prostatectomy RP or radiation therapy RT Although most men are cured after this therapy approximately 30000-50000 annually in the US will develop recurrence after RP For most of these patients recurrence will be defined by biochemical recurrence BCR a rise in PSA with no other documented evidence of recurrence Patients with BCR typically receive radiation therapy to the prostate bed However about 50 of these patients will develop distant recurrence outside of the pelvis and require systemic therapy
Satraplatin is a third generation orally administered platinum compound Early clinical studies demonstrated activity in tumors of the ovary and lung in addition to prostate cancer Satraplatin has shown activity in prostate cancer in Phase II studies and has been evaluated in a pivotal Phase III study The SPARC trialas a single agent as second line therapy
There were approximately 232000 cases of prostate cancer diagnosed in the US in 2005 Most patients present with localized disease and undergo curative therapy either radical prostatectomy RP or radiation therapy RT Although most men are cured after this therapy approximately 30000-50000 annually in the US will develop recurrence after RP For most of these patients recurrence will be defined by biochemical recurrence BCR a rise in PSA with no other documented evidence of recurrence Patients with BCR typically receive radiation therapy to the prostate bed However about 50 of these patients will develop distant recurrence outside of the pelvis and require systemic therapy
Satraplatin is a third generation orally administered platinum compound Early clinical studies demonstrated activity in tumors of the ovary and lung in addition to prostate cancer Satraplatin has shown activity in prostate cancer in Phase II studies and has been evaluated in a pivotal Phase III study The SPARC trialas a single agent as second line therapy
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