A Phase II Trial of AMG 386 (IND# ), a Selective Angiopoietin ½ Neutralizing Peptibody, in Patients With Persistent/Recurrent Carcinoma of the Endometrium
OBJECTIVES:
Primary
- To estimate the proportion of patients with persistent or recurrent endometrial cancer,
who survive progression-free for at least 6 months and the proportion of patients who
have objective tumor response (complete or partial), treated with angiopoietin
1/2-neutralizing peptibody AMG 386 (AMG 386).
- To assess the frequency of objective tumor response in patients treated with this
regimen.
- To determine the nature and degree of toxicity of this regimen in these patients.
Secondary
- To determine the duration of progression-free survival and overall survival of patients
treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive angiopoietin 1/2-neutralizing peptibody AMG 386 IV over 30-60 minutes on
days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
Interventional
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival for at least 6 months
No
Kathleen N. Moore, MD
Principal Investigator
Oklahoma University Cancer Institute
United States: Federal Government
GOG-0229L
NCT01210222
July 2011
Name | Location |
---|---|
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Hartford Hospital | Hartford, Connecticut 06102-5037 |
Sarasota Memorial Hospital | Sarasota, Florida 34239 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |
Munson Medical Center | Traverse City, Michigan 49684 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
AnMed Health Cancer Center | Anderson, South Carolina 29621 |
Memorial Medical Center | Springfield, Illinois 62781 |
Nebraska Methodist Hospital | Omaha, Nebraska 68114 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Ohio State University Medical Center | Columbus, Ohio 43210 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
Virginia Commonwealth University | Richmond, Virginia |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
McFarland Clinic | Ames, Iowa 50010 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
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 |
Mercy Health Partners-Mercy Campus | Muskegon, Michigan 49443 |
Cox Medical Center | Springfield, Missouri 65807 |
Upstate Carolina CCOP | Spartanburg, South Carolina 29303 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
Maine Medical Center-Bramhall Campus | Portland, Maine 04102 |
Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Spectrum Health Reed City Hospital | Reed City, Michigan 49677 |
Saint Francis Hospital | Greenville, South Carolina 29601 |
Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale, Illinois 60521 |
Saint Vincent Oncology Center | Indianapolis, Indiana 46260 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |
Island Gynecologic Oncology | Brightwaters, New York 11718 |