Spots Global Cancer Trial Database for Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer
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Trial Identification
Brief Title: Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer
Official Title: A Phase II Evaluation of BIBF 1120 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Study ID: NCT01225887
Conditions
Interventions
Study Description
Brief Summary: This phase II trial studies the side effects and how well nintedanib works in treating patients with endometrial cancer that has come back. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
Detailed Description: PRIMARY OBJECTIVES: I. 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 and the proportion of patients who have objective tumor response (complete or partial), treated with BIBF 1120 (nintedanib). II. To determine the nature and degree of toxicity of BIBF 1120 in this cohort of patients. SECONDARY OBJECTIVES: I. To estimate the progression-free survival (PFS) and overall survival (OS) of patients with persistent or recurrent endometrial cancer treated with BIBF 1120. OUTLINE: Patients receive nintedanib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, United States
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States
Memorial University Medical Center, Savannah, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Northwestern University, Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
Sudarshan K Sharma MD Limted-Gynecologic Oncology, Hinsdale, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Saint Vincent Oncology Center, Indianapolis, Indiana, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute, Baltimore, Maryland, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Genesys Regional Medical Center, Grand Blanc, Michigan, United States
Allegiance Health, Jackson, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Saint Mary Mercy Hospital, Livonia, Michigan, United States
Saint Joseph Mercy Port Huron, Port Huron, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Women's Cancer Center of Nevada, Las Vegas, Nevada, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Carolinas HealthCare System NorthEast, Concord, North Carolina, United States
Akron General Medical Center, Akron, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States
Lake University Ireland Cancer Center, Mentor, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Lankenau Medical Center, Wynnewood, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
Pacific Gynecology Specialists, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Swedish Medical Center-First Hill, Seattle, Washington, United States
Northwest Hospital, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, United States
Saint Vincent Hospital, Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay, Wisconsin, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Holy Family Memorial Hospital, Manitowoc, Wisconsin, United States
Bay Area Medical Center, Marinette, Wisconsin, United States
Contact Details
Name: Don Dizon
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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