A Phase II Evaluation of VEGF-Trap (NSC #724770, IND #BB100137, NCI-Supplied Agent) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
PRIMARY OBJECTIVES:
I. Assess the activity of VEGF Trap in patients with recurrent or persistent endometrial
cancer, in terms of the frequency of patients who have progression-free survival for at
least 6 months after initiating therapy or have objective tumor response.
II. Determine the toxicity of this drug in these patients.
SECONDARY OBJECTIVES:
I. Determine the duration of progression-free survival and overall survival of patients
treated with this drug.
OUTLINE:
Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
At 6 months
No
Robert Coleman
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2009-00597
NCT00462826
November 2007
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Gynecologic Oncology Network | Greenville, North Carolina 27858 |
Hartford Hospital | Hartford, Connecticut 06102-5037 |
Franklin Square Hospital Center | Baltimore, Maryland 21237 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Shawnee Mission Medical Center | Shawnee Mission, Kansas 66204 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Research Medical Center | Kansas City, Missouri 64132 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Washington Hospital Center | Washington, District of Columbia 20010 |
Fairview Hospital | Cleveland, Ohio 44111 |
Providence Medical Center | Kansas City, Kansas 66112 |
Independence Regional Health Center | Independence, Missouri 64050 |
Northwestern University | Chicago, Illinois 60611 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
University of New Mexico | Albuquerque, New Mexico 87131 |
Florida Hospital | Orlando, Florida 32803 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
Hillcrest Hospital Cancer Center | Mayfield Heights, Ohio 44124 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
M D Anderson Cancer Center | Houston, Texas 77030 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
Saint Vincent Hospital and Health Services | Indianapolis, Indiana 46260 |
Radiation Oncology Practice Corporation Southwest | Overland Park, Kansas 66210 |
Green Bay Oncology - Escanaba | Escanaba, Michigan 49431 |
Green Bay Oncology - Iron Mountain | Iron Mountain, Michigan 49801 |
Radiation Oncology Practice Corporation - North | Kansas City, Missouri 64154 |
Saint Luke's Cancer Institute | Kansas City, Missouri 64111 |
Radiation Oncology Practice Corporation South | Kansas City, Missouri 64114 |
Saint Luke's Hospital of Kansas City | Kansas City, Missouri 64111 |
Saint Joseph Health Center | Kansas City, Missouri 64114 |
Liberty Radiation Oncology Clinic | Kansas City, Missouri 64116 |
Truman Medical Center | Kansas City, Missouri 64108 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Mount Carmel Health Center West | Columbus, Ohio 43222 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Green Bay Oncology at Saint Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Green Bay Oncology - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Cancer Care Associates-Midtown | Tulsa, Oklahoma 74104 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
Jupiter Medical Center | Jupiter, Florida 33458 |
University of Illinois | Chicago, Illinois 60612 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
Carilion Clinic Gynecological Oncology | Roanoke, Virginia 24016 |
Northwest Medical Specialties PLLC | Tacoma, Washington 98405 |
Southwest Gynecologic Oncology Associates Inc | Albuquerque, New Mexico 87106 |
Radiation Oncology Center of Olathe | Olathe, Kansas 66061 |