Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321646
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2006-05-02
Brief Title:
Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy
Sponsor:
Mary-Ellen Taplin MD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy
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 main purpose of this trial is to collect information and to evaluate the effects good or bad the combination of docetaxel and bevacizumab has on patients with high risk prostate cancer that are undergoing radical prostatectomy
Detailed Description:
Patients who are eligible for this study will undergo an endorectal MRI scan test before beginning the research study
After the MRI the patient will begin the docetaxel plus bevacizumab part of the study Each treatment cycle starts on the day you receive both drugs and lasts 21 days Patients will undergo a total of 6 cycles-5 with docetaxel plus bevacizumab and one with docetaxel alone
At the beginning of each cycle the patient will come into the clinic for a visit that will last about 3 hours The following will happen at these visits physical examination including vital signs and rectal exam questions about the patients health and the medications they are taking blood tests both routine and research blood tests urine tests bevacizumab infusion docetaxel infusion
The patients first dose of bevacizumab will be given on Day 1 of the first cycle over 90 minutes If the patient tolerates the 90-minute infusion well later doses may be given over a shorter period of time
The day before and the morning of the beginning of each cycle the patient will be given a steroid called dexamethasone in pill form to help decrease the side effects of the treatment
The above tests and procedures will be repeated every 21 days a total of five times For the sixth time the patient will have all the same tests and procedures except they will not receive bevacizumab
After the six cycles the patient will undergo another endorectal MRI
One to two months after finishing the sixth cycle the patient will undergo a radical prostatectomy to remove their prostate
Two to three months after the surgery the patient will return to the clinic to have the following tests and procedures questions about the patients health routine blood tests and research blood tests
After the MRI the patient will begin the docetaxel plus bevacizumab part of the study Each treatment cycle starts on the day you receive both drugs and lasts 21 days Patients will undergo a total of 6 cycles-5 with docetaxel plus bevacizumab and one with docetaxel alone
At the beginning of each cycle the patient will come into the clinic for a visit that will last about 3 hours The following will happen at these visits physical examination including vital signs and rectal exam questions about the patients health and the medications they are taking blood tests both routine and research blood tests urine tests bevacizumab infusion docetaxel infusion
The patients first dose of bevacizumab will be given on Day 1 of the first cycle over 90 minutes If the patient tolerates the 90-minute infusion well later doses may be given over a shorter period of time
The day before and the morning of the beginning of each cycle the patient will be given a steroid called dexamethasone in pill form to help decrease the side effects of the treatment
The above tests and procedures will be repeated every 21 days a total of five times For the sixth time the patient will have all the same tests and procedures except they will not receive bevacizumab
After the six cycles the patient will undergo another endorectal MRI
One to two months after finishing the sixth cycle the patient will undergo a radical prostatectomy to remove their prostate
Two to three months after the surgery the patient will return to the clinic to have the following tests and procedures questions about the patients health routine blood tests and research blood tests
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