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Spots Global Cancer Trial Database for Brivanib Alaninate in Treating Patients With Persistent or Recurrent Cervical Cancer

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: John K Chan

Affiliation: NRG Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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