Malignant Ovarian Epithelial Tumor Clinical Trial
Official title:
A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC# 704865) for Recurrent Sex Cord-Stromal Tumors of the Ovary
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.
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.
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