Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-25 @ 3:06 PM
Study NCT ID:
NCT00071968
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2003-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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:
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 pharmacodynamic/pharmacogenomic 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 pharmacodynamic/pharmacogenomic 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 pharmacodynamic/pharmacogenomic 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 pharmacodynamic/pharmacogenomic 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?: