NCT00748657

Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary

A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC# 704865) for Recurrent Sex Cord-Stromal Tumors of the Ovary

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Ovarian Epithelial Tumor
• Ovarian Granulosa Cell Tumor
• Ovarian Gynandroblastoma
• Ovarian Sertoli-Leydig Cell Tumor
• Ovarian Sex Cord Tumor With Annular Tubules
• Ovarian Sex Cord-Stromal Tumor
• Ovarian Sex Cord-Stromal Tumor of Mixed or Unclassified Cell Types
• Ovarian Steroid Cell Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2008-09-22
• Primary completion: 2013-01-31
• Completion: 2013-01-31
• First posted: 2008-09-08
• Last updated: 2019-07-23
• Results posted: 2015-06-10

Locations

36 sites across 1 country: United States