748657
Last Update Posted: 2019-07-23
Recruiting has ended
Females accepted | 18 Years + |
36 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Bevacizumab in Treating Patients With 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.
Eligibility
Relevant 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
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov