Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110214
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2005-05-04
Brief Title:
Docetaxel and Prednisone With or Without Bevacizumab in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Double-Blinded Placebo Controlled Phase III Trial Comparing Doctaxel and Prednisone With and Without Bevacizumab IND 7921 NSC 704865 in Men With Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2012-12
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 randomized phase III trial is studying docetaxel prednisone and bevacizumab to see how well they work compared to docetaxel and prednisone in treating patients with prostate cancer that did not respond to hormone therapy Drugs used in chemotherapy such as docetaxel and prednisone work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor It is not yet known whether docetaxel prednisone and bevacizumab are more effective than docetaxel and prednisone in treating prostate cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine if the addition of bevacizumab to docetaxel and prednisone increases overall survival compared to docetaxel and prednisone alone in patients with HRPC
SECONDARY OBJECTIVES
I To compare the progression-free survival of these two regimens in patients with HRPC
II To compare the two regimens on the proportion of patients who experience a 50 post-therapy PSA decline from baseline
III To compare the two regimens with respect to the proportion of patients who experience grade 3 or higher toxicities
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to predicted 24-month survival probability 10 vs 10-299 vs 30 age 65 years vs 65 years and prior history of arterial events ie cardiac ischemiainfarction CNS cerebrovascular ischemia peripheral arterial ischemia or CNS hemorrhage yes vs no Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive docetaxel IV over 1 hour and placebo IV over 30-90 minutes on day 1 Patients also receive oral prednisone once daily on days 1-21
ARM II Patients receive docetaxel and prednisone as in arm I Patients also receive bevacizumab IV over 30-90 minutes on day 1
In both arms courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 5 years
I To determine if the addition of bevacizumab to docetaxel and prednisone increases overall survival compared to docetaxel and prednisone alone in patients with HRPC
SECONDARY OBJECTIVES
I To compare the progression-free survival of these two regimens in patients with HRPC
II To compare the two regimens on the proportion of patients who experience a 50 post-therapy PSA decline from baseline
III To compare the two regimens with respect to the proportion of patients who experience grade 3 or higher toxicities
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to predicted 24-month survival probability 10 vs 10-299 vs 30 age 65 years vs 65 years and prior history of arterial events ie cardiac ischemiainfarction CNS cerebrovascular ischemia peripheral arterial ischemia or CNS hemorrhage yes vs no Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive docetaxel IV over 1 hour and placebo IV over 30-90 minutes on day 1 Patients also receive oral prednisone once daily on days 1-21
ARM II Patients receive docetaxel and prednisone as in arm I Patients also receive bevacizumab IV over 30-90 minutes on day 1
In both arms courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 5 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA031946 | NIH | CTEP | httpsreporternihgovquickSearchU10CA031946 |
| NCI-2012-02814 | REGISTRY | None | None |
| CDR0000427290 | None | None | None |
| CALGB-90401 | OTHER | None | None |
| CALGB-90401 | OTHER | None | None |
| P30CA014236 | NIH | None | None |