Spots Global Cancer Trial Database for Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer
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Trial Identification
Brief Title: Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer
Official Title: A Phase II Trial of AMG 386, a Selective Angiopoietin 1/2 Neutralizing Peptibody, in Patients With Persistent/Recurrent Carcinoma of the Endometrium
Study ID: NCT01210222
Interventions
Study Description
Brief Summary: This phase II trial studies the side effects and how well trebananib works in treating patients with persistent or recurrent endometrial cancer. Trebananib may stop the growth of endometrial cancer 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 for at least 6 months and the proportion of patients who have objective tumor response (complete or partial), treated with AMG 386 (trebananib). II. To determine the nature and degree of toxicity of AMG 386 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 AMG 386. OUTLINE: Patients receive trebananib intravenously (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 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
Hartford Hospital, Hartford, Connecticut, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Sarasota Memorial Hospital, Sarasota, Florida, United States
Memorial University Medical Center, Savannah, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Sudarshan K Sharma MD Limted-Gynecologic Oncology, Hinsdale, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, United States
McFarland Clinic PC-William R Bliss Cancer Center, Ames, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Iowa-Wide Oncology Research Coalition NCORP, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
Iowa Lutheran Hospital, Des Moines, Iowa, United States
Maine Medical Center-Bramhall Campus, Portland, Maine, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, North Carolina, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Riverside Methodist Hospital, Columbus, 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
Women and Infants Hospital, Providence, Rhode Island, United States
AnMed Health Cancer Center, Anderson, South Carolina, United States
Saint Francis Hospital, Greenville, South Carolina, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Contact Details
Name: Kathleen Moore
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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