Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071968
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2003-11-04
Brief Title:
Neoadjuvant CCI-779 Followed By Radical Prostatectomy in Treating Patients With Newly Diagnosed Prostate Cancer Who Have a High Risk of Relapse
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
An Open-Label Study Of Exploratory Pharmacogenomics And Pharmacologic Effects Of Neoadjuvant Oral CCI-779 In Newly Diagnosed Prostate Cancer Patients Undergoing Radical Prostatectomy Who Have A High Risk Of Relapse
Status:
COMPLETED
Status Verified Date:
2013-01
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 CCI-779 work in different ways to stop tumor cells from dividing so they stop growing or die Giving CCI-779 before surgery may shrink the tumor so that it can be removed
PURPOSE This randomized phase II trial is studying how well CCI-779 works in treating patients who are undergoing radical prostatectomy for newly diagnosed prostate cancer at high risk of relapse
PURPOSE This randomized phase II trial is studying how well CCI-779 works in treating patients who are undergoing radical prostatectomy for newly diagnosed prostate cancer at high risk of relapse
Detailed Description:
OBJECTIVES
Primary
Determine the effects of oral CCI-779 on changes in the phosphorylation state of proteins in the mammalian target of rapamycin mTOR signaling pathway in the tumor tissue of patients with newly diagnosed prostate cancer undergoing radical prostatectomy
Determine the effects of this drug on changes in p70S6 kinase activity phosphorylation state of mTOR pathway proteins and on global and targeted gene expression patterns in the peripheral blood mononuclear cells PBMCs of these patients
Secondary
Determine the effects of this drug on global and targeted gene expression patterns in these patients
Identify pharmacodynamicpharmacogenomic surrogate markers of this drug in both tumor tissue and PBMCs and determine if blood may be used as a surrogate tissue source for biomarkers of drug activity in the tumor in these patients
Determine preliminarily the potential antitumor effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Correlate phosphatase and tensin homolog PTEN gene status with the pharmacodynamicpharmacogenomic effects of this drug in these patients
Determine the effects of this drug on changes in protein expression patterns in the plasma of these patients
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 3 treatment arms Patients randomized to arm III are stratified according to tumor expression of phosphatase and tensin homolog PTEN gene mutations negative vs positive
Arm I Patients receive oral CCI-779 once daily for a total of 8 weeks
Arm II Patients receive a higher dose of CCI-779 as in arm I
Arm III Patients receive a higher dose higher than arm II of CCI-779 as in arm I
Approximately 24-48 hours after the last dose of CCI-779 patients in all arms undergo radical prostatectomy
Patients are followed on day 7-10 and then at 4 weeks after study completion
PROJECTED ACCRUAL A total of 40 patients 5 each for arms I and II and 30 for arm III will be accrued for this study
Primary
Determine the effects of oral CCI-779 on changes in the phosphorylation state of proteins in the mammalian target of rapamycin mTOR signaling pathway in the tumor tissue of patients with newly diagnosed prostate cancer undergoing radical prostatectomy
Determine the effects of this drug on changes in p70S6 kinase activity phosphorylation state of mTOR pathway proteins and on global and targeted gene expression patterns in the peripheral blood mononuclear cells PBMCs of these patients
Secondary
Determine the effects of this drug on global and targeted gene expression patterns in these patients
Identify pharmacodynamicpharmacogenomic surrogate markers of this drug in both tumor tissue and PBMCs and determine if blood may be used as a surrogate tissue source for biomarkers of drug activity in the tumor in these patients
Determine preliminarily the potential antitumor effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Correlate phosphatase and tensin homolog PTEN gene status with the pharmacodynamicpharmacogenomic effects of this drug in these patients
Determine the effects of this drug on changes in protein expression patterns in the plasma of these patients
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 3 treatment arms Patients randomized to arm III are stratified according to tumor expression of phosphatase and tensin homolog PTEN gene mutations negative vs positive
Arm I Patients receive oral CCI-779 once daily for a total of 8 weeks
Arm II Patients receive a higher dose of CCI-779 as in arm I
Arm III Patients receive a higher dose higher than arm II of CCI-779 as in arm I
Approximately 24-48 hours after the last dose of CCI-779 patients in all arms undergo radical prostatectomy
Patients are followed on day 7-10 and then at 4 weeks after study completion
PROJECTED ACCRUAL A total of 40 patients 5 each for arms I and II and 30 for arm III will be accrued for this study
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 |
|---|---|---|---|
| WYETH-C-3066A1-132-US | None | None | None |
| UCLA-0306091 | None | None | None |