Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary
This phase II trial is studying how well bevacizumab works in treating patients with recurrent sex cord-stromal tumors of the ovary. 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC 704865, IND 7921) for Recurrent Sex Cord-Stromal Tumors of the Ovary|
- Tumor response rate (complete and partial response) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From entry into the study to death or the date of last contact, up to 5 years ] [ Designated as safety issue: No ]Overall survival will be estimated and graphed using the Kaplan-Meier product-limit method.
- Progression-free survival [ Time Frame: From study entry until disease progression, death or date of last contact, up to 5 years ] [ Designated as safety issue: No ]Progression free survival will be estimated and graphed using the Kaplan-Meier product-limit method.
- Frequency and severity of adverse events as assessed by Common Terminology for Adverse Events version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (bevacizumab)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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.
I. To determine the nature and degree of toxicity of this drug in these patients.
II. To determine the overall survival and progression-free survival of these patients.
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: This is a multicenter study.
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 therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then periodically thereafter.