Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016107
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2001-05-06
Brief Title:
Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of Estramustine Docetaxel And Bevacizumab IND 7921 NSC 704865 In Men With Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Phase II trial to study the effectiveness of combination chemotherapy plus monoclonal antibody therapy in treating patients who have metastatic prostate cancer that has not responded to previous hormone therapy Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as bevacizumab may stop the growth of cancer cells by stopping blood flow to the tumor Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine time to objective progression response rate objective and PSA response and duration of response in men with hormone refractory prostate cancer treated with estramustine docetaxel and bevacizumab
II To determine the toxicity of this regimen in men with hormone refractory prostate cancer
III To study the relationship of baseline VEGF levels in urine and plasma and changes in these levels to response and duration of response to treatment with bevacizumab docetaxel and estramustine
OUTLINE
Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour followed by bevacizumab IV over 30-90 minutes on day 2 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed at least every 3 months for 2 years
I To determine time to objective progression response rate objective and PSA response and duration of response in men with hormone refractory prostate cancer treated with estramustine docetaxel and bevacizumab
II To determine the toxicity of this regimen in men with hormone refractory prostate cancer
III To study the relationship of baseline VEGF levels in urine and plasma and changes in these levels to response and duration of response to treatment with bevacizumab docetaxel and estramustine
OUTLINE
Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour followed by bevacizumab IV over 30-90 minutes on day 2 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed at least every 3 months for 2 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 |
|---|---|---|---|
| CALGB-90006 | None | None | None |
| CDR0000068595 | None | None | None |
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |