Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069888
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2003-10-02
Brief Title:
A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Open-Label Phase II Trial of Adjuvant Taxotere in Patients At High Risk of Relapse Following Prostatectomy
Status:
COMPLETED
Status Verified Date:
2011-06
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:
This clinical trial is designed to study whether docetaxel Taxotere helps reduce the risk of relapse in patients with prostate cancer who have had their prostate removed by surgery but are at high risk of their cancer recurring During the trial doctors will also closely monitor patients for side effects of the chemotherapy
Docetaxel is a chemotherapy drug that prevents tumor cells from dividing so they stop growing or die Doctors use docetaxel to treat lung and breast cancer and studies show it can help shrink tumors in some patients with prostate cancer that has spread to other parts of their bodies The researchers conducting this study want to determine if docetaxel also helps reduce the likelihood of prostate cancer returning after surgery has removed the original tumor
All of the study participants will receive up to 18 doses of docetaxel each administered through a needle inserted into a vein Each round of treatment will consist of 30-minute weekly infusions for three consecutive weeks followed by one week with no chemotherapy Before and after the chemotherapy patients will take dexamethasone an oral steroid that reduces the risk of an allergic reaction to the medication If the side effects of the treatment become too intense doctors may modify delay or even stop chemotherapy during the trial
Docetaxel is a chemotherapy drug that prevents tumor cells from dividing so they stop growing or die Doctors use docetaxel to treat lung and breast cancer and studies show it can help shrink tumors in some patients with prostate cancer that has spread to other parts of their bodies The researchers conducting this study want to determine if docetaxel also helps reduce the likelihood of prostate cancer returning after surgery has removed the original tumor
All of the study participants will receive up to 18 doses of docetaxel each administered through a needle inserted into a vein Each round of treatment will consist of 30-minute weekly infusions for three consecutive weeks followed by one week with no chemotherapy Before and after the chemotherapy patients will take dexamethasone an oral steroid that reduces the risk of an allergic reaction to the medication If the side effects of the treatment become too intense doctors may modify delay or even stop chemotherapy during the trial
Detailed Description:
None
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