Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459186
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2006-01-23
Brief Title:
The Use of RAD001 With Docetaxel in the Treatment of Metastatic Androgen Independent Prostate Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase III Study of RAD001 With Docetaxel in the Treatment of Metastatic Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2016-04
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:
The purpose of this study is to evaluate the safety and optimal dose of RAD001 and docetaxel plus prednisone in men with hormone refractory metastatic prostate cancer Phase I
Once an appropriate dose is reached the purpose then will be to determine the response rate of docetaxel plus RAD001 Phase II
Once an appropriate dose is reached the purpose then will be to determine the response rate of docetaxel plus RAD001 Phase II
Detailed Description:
Patients will be designated into one of two groups based upon the results of a FDG-PET scan
A patient with a baseline positive scan will have serum drawn for baseline serum proteomics assessment then be treated with RAD001 daily for two weeks On day 10-14 another FDG-PET scan and serum assessment will be performed An optional bone marrow biopsy may also be done On day 15 patients will enter the Phase I portion of the trial at the current enrolling dosage or if Phase I is completed patients will enter Phase II
A patient that does not have a positive scan will enter directly into the Phase I trial or Phase II depending on which trial is currently enrolling
Phase I trial patients will have weekly laboratory evaluations and clinical evaluation every three weeks
Phase II trial patients will have laboratory evaluations on day one and day eight and clinical evaluation every three weeks
The maximum duration of the trial is one year of therapy
A patient with a baseline positive scan will have serum drawn for baseline serum proteomics assessment then be treated with RAD001 daily for two weeks On day 10-14 another FDG-PET scan and serum assessment will be performed An optional bone marrow biopsy may also be done On day 15 patients will enter the Phase I portion of the trial at the current enrolling dosage or if Phase I is completed patients will enter Phase II
A patient that does not have a positive scan will enter directly into the Phase I trial or Phase II depending on which trial is currently enrolling
Phase I trial patients will have weekly laboratory evaluations and clinical evaluation every three weeks
Phase II trial patients will have laboratory evaluations on day one and day eight and clinical evaluation every three weeks
The maximum duration of the trial is one year of 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