A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC 704865, IND 7921) for Recurrent Sex Cord-Stromal Tumors of the Ovary
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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response rate (complete and partial response) assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Up to 5 years
Gynecologic Oncology Group
United States: Food and Drug Administration
|Memorial Sloan Kettering Cancer Center||New York, New York 10021|
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|
|University of Mississippi Medical Center||Jackson, Mississippi 39216-4505|
|Abington Memorial Hospital||Abington, Pennsylvania 19001|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Hartford Hospital||Hartford, Connecticut 06102-5037|
|Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|
|MetroHealth Medical Center||Cleveland, Ohio 44109|
|Methodist Estabrook Cancer Center||Omaha, Nebraska 68114-4199|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|Zale Lipshy University Hospital||Dallas, Texas 75235-7786|
|Northwestern University||Chicago, Illinois 60611|
|University of Massachusetts Medical School||Worcester, Massachusetts 01605|
|Riverside Methodist Hospital||Columbus, Ohio 43214|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|M D Anderson Cancer Center||Houston, Texas 77030|
|University of Southern California||Los Angeles, California 90033|
|The Hospital of Central Connecticut||New Britain, Connecticut 06050|
|Cancer Care Associates-Yale||Tulsa, Oklahoma 74136-1929|
|University of Minnesota Medical Center-Fairview||Minneapolis, Minnesota 55455|
|Los Angeles County-USC Medical Center||Los Angeles, California 90033|
|University of Massachusetts Memorial Health Care||Worcester, Massachusetts 01605|