Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00348998
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2006-07-05
Brief Title:
Bevacizumab Hormone Therapy and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer
Sponsor:
Virginia Mason HospitalMedical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2008-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE 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 Androgens can cause the growth of prostate cancer cells Drugs such as goserelin and bicalutamide may stop the adrenal glands from making androgens Radiation therapy uses high-energy x-rays to kill tumor cells Bevacizumab may also make tumor cells more sensitive to radiation therapy Giving bevacizumab together with hormone therapy and radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving bevacizumab together with hormone therapy and radiation therapy works in treating patients with high-risk locally advanced prostate cancer
PURPOSE This phase II trial is studying how well giving bevacizumab together with hormone therapy and radiation therapy works in treating patients with high-risk locally advanced prostate cancer
Detailed Description:
OBJECTIVES
Determine the safety and efficacy of giving bevacizumab together with hormonal therapy and radiotherapy in patients with high-risk locally advanced prostate cancer
OUTLINE This is an open-label pilot study
Beginning in week 1 patients receive goserelin subcutaneously once every 3 months for 2 years Patients also receive oral bicalutamide once daily and bevacizumab IV over 30- to 90-minutes once every 2 weeks in weeks 1-16 and undergo radiotherapy 5 days a week in weeks 9-16 After completion of radiotherapy patients receive a higher dose of bevacizumab once every 3 weeks in weeks 17-28
After completion of study treatment patients are evaluated at 30 days
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study
Determine the safety and efficacy of giving bevacizumab together with hormonal therapy and radiotherapy in patients with high-risk locally advanced prostate cancer
OUTLINE This is an open-label pilot study
Beginning in week 1 patients receive goserelin subcutaneously once every 3 months for 2 years Patients also receive oral bicalutamide once daily and bevacizumab IV over 30- to 90-minutes once every 2 weeks in weeks 1-16 and undergo radiotherapy 5 days a week in weeks 9-16 After completion of radiotherapy patients receive a higher dose of bevacizumab once every 3 weeks in weeks 17-28
After completion of study treatment patients are evaluated at 30 days
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study
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 |
|---|---|---|---|
| GENENTECH-AVF3549s | None | None | None |
| BRIVMRC-3031500 | None | None | None |