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Brief Title: Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary
Official Title: A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC# 704865) for Recurrent Sex Cord-Stromal Tumors of the Ovary
Study ID: NCT00748657
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Los Angeles County-USC Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
Hartford Hospital, Hartford, Connecticut, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Northeast Georgia Medical Center-Gainesville, Gainesville, Georgia, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Hinsdale Hematology Oncology Associates Incorporated, Hinsdale, Illinois, United States
Sudarshan K Sharma MD Limted-Gynecologic Oncology, Hinsdale, Illinois, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
University of Massachusetts Memorial Health Care, Worcester, Massachusetts, United States
University of Massachusetts Medical School, Worcester, Massachusetts, United States
University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Case Western Reserve University, Cleveland, Ohio, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Miami Valley Hospital, Dayton, Ohio, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States
Lake University Ireland Cancer Center, Mentor, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Parkland Memorial Hospital, Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
Name: Jubilee Brown
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR