Cervical Adenocarcinoma Clinical Trial
Official title:
A Phase II Evaluation of Brivanib (BMS582664) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix (BMS Study CA182-048)
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.
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.
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