Ignite Creation Date:
2025-12-17 @ 3:32 PM
Ignite Modification Date:
2025-12-23 @ 6:04 PM
Study NCT ID:
NCT00748657
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2008-09-05
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC# 704865) for Recurrent Sex Cord-Stromal Tumors of the Ovary
Status:
COMPLETED
Status Verified Date:
2019-07
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 phase II trial studies how well bevacizumab works in treating patients with sex cord-stromal tumors of the ovary that have come back. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.
Detailed Description:
PRIMARY OBJECTIVES:
I. To estimate the anti-tumor activity of bevacizumab by assessing frequency of objective response in patients with recurrent sex cord-stromal tumors of the ovary who have measurable disease.
SECONDARY OBJECTIVES:
I. To determine the nature and degree of toxicity in these patients. II. To determine the overall survival and progression-free survival of these patients.
TERTIARY OBJECTIVES:
I. To quantify expression of angiogenic or lymphangiogenic markers in recurrent stromal tumors of the ovary to determine the frequency of alterations and potential utility of biologic agents directed at these proteins for inclusion in future studies.
OUTLINE:
Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then periodically thereafter.
I. To estimate the anti-tumor activity of bevacizumab by assessing frequency of objective response in patients with recurrent sex cord-stromal tumors of the ovary who have measurable disease.
SECONDARY OBJECTIVES:
I. To determine the nature and degree of toxicity in these patients. II. To determine the overall survival and progression-free survival of these patients.
TERTIARY OBJECTIVES:
I. To quantify expression of angiogenic or lymphangiogenic markers in recurrent stromal tumors of the ovary to determine the frequency of alterations and potential utility of biologic agents directed at these proteins for inclusion in future studies.
OUTLINE:
Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then periodically thereafter.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2009-00611 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000613531 | None | None | View | |
| GOG-0251 | None | None | View | |
| GOG-0251 | OTHER | NRG Oncology | View | |
| GOG-0251 | OTHER | CTEP | View | |
| U10CA180868 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10CA027469 | NIH | None | https://reporter.nih.gov/quic… | View |