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Brief Title: Brivanib Alaninate in Treating Patients With Persistent or Recurrent Cervical Cancer
Official Title: A Phase II Evaluation of Brivanib (BMS582664) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix (BMS Study CA182-048)
Study ID: NCT01267253
Brief Summary: This phase II trial studies how well brivanib alaninate works in treating patients with cervical cancer that has come back. Brivanib alaninate 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 cervical 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 brivanib (brivanib alaninate). II. To determine the nature and degree of toxicity of brivanib 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 cervical cancer treated with brivanib. TERTIARY OBJECTIVES: I. To obtain the serum expression levels of surrogate markers of brivanib effects including angiogenic factors (vascular endothelial growth factor \[VEGF\] and basic fibroblast growth factor \[bFGF\]) and markers of endothelial damage (E-selectin, vascular cell adhesion molecule 1 \[VCAM-1\], and (intercellular adhesion molecule 1 \[ICAM-1\]). (exploratory) II. To determine whether these marker expression levels alone or in combination are associated with response, PFS, or overall survival. (exploratory) OUTLINE: Patients receive brivanib alaninate orally (PO) once daily (QD) 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Saint Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Beebe Medical Center, Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Florida Hospital Orlando, Orlando, Florida, United States
Sarasota Memorial Hospital, Sarasota, Florida, United States
Memorial Health 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 Limited-Gynecologic Oncology, Hinsdale, Illinois, United States
Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Union Hospital of Cecil County, Elkton, Maryland, United States
Baystate Medical Center, Springfield, Massachusetts, United States
Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Saint Mary Mercy Hospital, Livonia, Michigan, United States
Saint Joseph Mercy Oakland, Pontiac, Michigan, United States
Lake Huron Medical Center, Port Huron, Michigan, 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
Women's Cancer Center of Nevada, Las Vegas, Nevada, United States
Cooper Hospital University Medical Center, Camden, New Jersey, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Summa Akron City Hospital/Cooper Cancer Center, Akron, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus, 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
West Penn Hospital, Pittsburgh, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
Baylor All Saints Medical Center at Fort Worth, Fort Worth, Texas, United States
Lyndon Baines Johnson General Hospital, Houston, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Name: John K Chan
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR