A Phase II Evaluation of BIBF 1120 (IND #) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
OBJECTIVES:
Primary
- To estimate the proportion of patients with persistent or recurrent endometrial cancer,
who survive progression-free without going on a subsequent therapy against the disease
for at least 6 months
- To assess objective tumor response (complete or partial) in patients with recurrent or
persistent endometrial carcinoma treated with BIBF 1120.
- To determine the nature and degree of toxicity of BIBI 1120 in these patients.
Secondary
- To estimate the progression-free survival (PFS) and overall survival (OS) of patients
with persistent or recurrent endometrial cancer treated with BIBF 1120.
OUTLINE: This is a multicenter study.
Patients receive oral BIBF 1120 twice daily on days 1-28. 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
Masking: Open Label, Primary Purpose: Treatment
Progression-free survival for at least 6 months
No
Don S. Dizon, MD
Principal Investigator
Women and Infants Hospital of Rhode Island
United States: Federal Government
GOG-0229K
NCT01225887
October 2011
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
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 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Hurley Medical Center | Flint, Michigan 48503 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Akron General Medical Center | Akron, Ohio 44302 |
Franklin Square Hospital Center | Baltimore, Maryland 21237 |
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 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
Pacific Gynecology Specialists | Seattle, Washington 98104 |
Northwestern University | Chicago, Illinois 60611 |
Nebraska Methodist Hospital | Omaha, Nebraska 68114 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
University of Texas Southwestern Medical Center | Dallas, Texas |
Northwest Hospital | Seattle, Washington 98133 |
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |
Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
Hillcrest Hospital Cancer Center | Mayfield Heights, Ohio 44124 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Evanston CCOP-NorthShore University HealthSystem | Evanston, Illinois 60201 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Allegiance Health | Jackson, Michigan 49201 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Green Bay Oncology Limited at 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 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
Carolinas Medical Center - Northeast | Concord, North Carolina 28025 |
Holy Family Memorial Hospital | Manitowoc, Wisconsin 54221 |
Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale, Illinois 60521 |
Saint Vincent Oncology Center | Indianapolis, Indiana 46260 |
Gynecologic Oncology Group | Philadelphia, Pennsylvania 19103 |
Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland, Ohio 44111 |