A Phase II Evaluation of Combination Bevacizumab (NCI-Supplied Agent: NSC #704865, IND #7921) and Temsirolimus (CCI-779, NCI-Supplied Agent, NSC #683864, IND #61010) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
PRIMARY OBJECTIVES:
I. To assess the activity of bevacizumab and temsirolimus, in terms of 6-month
progression-free survival (PFS) and objective tumor response, in patients with recurrent or
persistent endometrial cancer.
II. To determine the nature and degree of toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. To determine the duration of PFS and overall survival of patients treated with this
regimen.
II. To determine the effects of prognostic factors (i.e., performance status, histological
subtype, and grade) in patients treated with this regimen.
TERTIARY OBJECTIVES:
I. To compare the proportion of patients with objective tumor response and PFS at 6 months
receiving the combination of bevacizumab and temsirolimus with those for the single agents
bevacizumab and temsirolimus using historical controls.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV on days 1 and 15 and temsirolimus IV on days 1, 8, 15, and
22. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity.
After completion of study therapy, patients are followed every 3 months for 2 years, then
every 6 months for 3 years, for a total of 5 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients who survive progression-free
At 6 months
No
Edwin Alvarez
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2009-00598
NCT00723255
September 2008
Name | Location |
---|---|
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 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Gynecologic Oncology Network | Greenville, North Carolina 27858 |
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 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
South Bend Clinic | South Bend, Indiana 46617 |
AnMed Health Cancer Center | Anderson, South Carolina 29621 |
Washington Hospital Center | Washington, District of Columbia 20010 |
Independence Regional Health Center | Independence, Missouri 64050 |
Saint Louis University Hospital | St. Louis, Missouri 63110-0250 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
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 |
Lakeland Hospital | St. Joseph, Michigan 49085 |
Truman Medical Center | Kansas City, Missouri 64108 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
Gynecologic Oncology of West Michigan PLLC | Grand Rapids, Michigan 49546 |
Carilion Clinic Gynecological Oncology | Roanoke, Virginia 24016 |
Community Howard Regional Health | Kokomo, Indiana 46904 |
Indiana University Health La Porte Hospital | La Porte, Indiana 46350 |
Saint Joseph Regional Medical Center-Mishawaka | Mishawaka, Indiana 46545-1470 |
Women's Cancer Care Associates LLC | Albany, New York 12208 |