A Phase II Evaluation of Brivanib (BMS582664, IND #108417) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix (BMS Study CA182-048)
OBJECTIVES:
Primary
- To assess the activity of brivanib for patients with persistent or recurrent carcinoma
of the cervix with the frequency of patients who survive progression free for at least
6 months after initiating therapy or have objective tumor response.
- To determine the nature and degree of toxicity of brivanib as assessed by the NCI
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 in this cohort of
patients.
Secondary
- To characterize the distribution of progression-free survival (PFS) and overall
survival.
- To determine the effect of brivanib on the duration of objective response in persistent
or recurrent carcinoma of the cervix.
Tertiary
- To obtain the serum expression levels of surrogate markers of brivanib effects
including angiogenic factors (VEGF and bFGF) and markers of endothelial damage
(E-selectin, VCAM-1, and ICAM-1). (exploratory)
- To determine whether these marker expression levels alone or in combination are
associated with response, PFS, or overall survival. (exploratory)
OUTLINE: This is a multicenter study.
Patients receive oral brivanib once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
Serum samples may be collected periodically for correlative biomarker studies.
After completion of study therapy, patients are followed up every 3 months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Progression-free for at least 6 months
No
John K. Chan, MD
Principal Investigator
University of California, San Francisco
United States: Federal Government
CDR0000690083
NCT01267253
April 2011
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield, Massachusetts 01199 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
St. Joseph's Hospital and Medical Center | Phoenix, Arizona 85001-2071 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Sarasota Memorial Hospital | Sarasota, Florida 34239 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Cancer Care Associates - Saint Francis Campus | Tulsa, Oklahoma 74136-1929 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Greater Baltimore Medical Center Cancer Center | Baltimore, Maryland 21204 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Gynecologic Oncology | Hinsdale, Illinois 60521 |
Women's Cancer Center - La Canada | Las Vegas, Nevada 89169 |
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center | Burbank, California 91505 |
Lyndon B. Johnson General Hospital | Houston, Texas 77026-1967 |
St. Vincent Oncology Center | Indianapolis, Indiana 46260 |
All Saints Episcopal Hospital - Fort Worth | Fort Worth, Texas 76104 |