A Randomized Phase II Trial of Temsirolimus (NCI-Supplied Agent, NSC # 683864, IND # 61010) or the Combination of Hormonal Therapy Plus Temsirolimus in Women With Advanced, Persistent, or Recurrent Endometrial Carcinoma
PRIMARY OBJECTIVES:
I. To determine the response rate in patients with advanced, persistent, or recurrent
endometrial carcinoma treated with temsirolimus with or without hormonal therapy comprising
megestrol acetate and tamoxifen citrate.
II. To determine the time to progression and number of patients remaining on study therapy
at 24 weeks.
SECONDARY OBJECTIVE:
III. To describe the toxicities of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment
for endometrial carcinoma (adjuvant chemotherapy or chemoradiotherapy at the time of initial
diagnosis or for a pelvic recurrence vs no adjuvant chemotherapy or chemoradiotherapy at the
time of initial diagnosis or for a pelvic recurrence). Patients are randomized to 1 of 2
treatment arms (arm II closed to accrual as of 12/21/09).
ARM I: Patients receive temsirolimus IV over 30 minutes once weekly for 6 weeks. Courses
repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
ARM II (closed to accrual as of 12/21/09): Patients receive temsirolimus as in arm I.
Patients also receive oral megestrol acetate twice daily for 3 weeks alternating with oral
tamoxifen citrate twice daily for 3 weeks.
Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 1 year.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Frequency of complete and partial clinical response, measured using GOG RECIST Criteria
Up to 1 year
No
Gini Fleming
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2009-01085
NCT00729586
September 2008
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Hurley Medical Center | Flint, Michigan 48503 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
North Shore University Hospital | Manhasset, New York 11030 |
Hartford Hospital | Hartford, Connecticut 06102-5037 |
Franklin Square Hospital Center | Baltimore, Maryland 21237 |
William Beaumont Hospital | Royal Oak, Michigan 48073 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
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 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Munson Medical Center | Traverse City, Michigan 49684 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Parkland Memorial Hospital | Dallas, Texas 75235 |
Beebe Medical Center | Lewes, Delaware 19958 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
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 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Liberty Hospital | Liberty, Missouri 64068 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Zale Lipshy University Hospital | Dallas, Texas 75235-7786 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
University of Virginia | Charlottesville, Virginia 22908 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
Independence Regional Health Center | Independence, Missouri 64050 |
University of California at San Diego | La Jolla, California 92093 |
University of Massachusetts Medical School | Worcester, Massachusetts 01605 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
University of Texas Southwestern Medical Center | Dallas, Texas |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
John B Amos Cancer Center | Columbus, Georgia 31904 |
Saint Vincent Hospital and Health Services | Indianapolis, Indiana 46260 |
Radiation Oncology Practice Corporation Southwest | Overland Park, Kansas 66210 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Green Bay Oncology - Escanaba | Escanaba, Michigan 49431 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan 49503 |
Green Bay Oncology - Iron Mountain | Iron Mountain, Michigan 49801 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Health Partners-Mercy Campus | Muskegon, Michigan 49443 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
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 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Legacy Good Samaritan Hospital and Medical Center | Portland, Oregon 97210 |
Northwest Cancer Specialists-Rose Quarter Cancer Center | Portland, Oregon 97227 |
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 |
Bay Area Medical Center | Marinette, Wisconsin 54143 |
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 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
Colorado Gynecologic Oncology Group | Aurora, Colorado 80010 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
Saint Paul Hospital | Dallas, Texas 75235 |
Holy Family Memorial Hospital | Manitowoc, Wisconsin 54221 |
Gynecologic Oncology of West Michigan PLLC | Grand Rapids, Michigan 49546 |
Monter Cancer Center | Lake Success, New York 11042 |
Black Hills Obstetrics and Gynecology | Rapid City, South Dakota 57701 |
Carilion Clinic Gynecological Oncology | Roanoke, Virginia 24016 |
University of Minnesota Medical Center-Fairview | Minneapolis, Minnesota 55455 |
Southwest Gynecologic Oncology Associates Inc | Albuquerque, New Mexico 87106 |
Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Saint Luke's South Hospital | Overland Park, Kansas 66213 |
Heartland Hematology and Oncology Associates Incorporated | Kansas City, Missouri 64118 |
Saint Joseph Oncology Inc | Saint Joseph, Missouri 64507 |
Gundersen Lutheran | La Crosse, Wisconsin 54601 |
Stanford University Hospitals and Clinics | Stanford, California 94305 |
Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale, Illinois 60521 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |
Women's Cancer Care Associates LLC | Albany, New York 12208 |
Providence Cancer Center -The Plaza | Portland, Oregon 97213 |