Brivanib in Treating Patients With Persistent or Recurrent Cervical Cancer
RATIONALE: Brivanib 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.
PURPOSE: This phase II trial is studying how well brivanib works in treating patients with persistent or recurrent cervical cancer.
Drug: brivanib alaninate
Other: laboratory biomarker analysis
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Brivanib (BMS582664, IND #108417) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix (BMS Study CA182-048)|
- Progression-free for at least 6 months [ Designated as safety issue: No ]
- Objective tumor response (complete or partial) [ Designated as safety issue: No ]
- Adverse events as assessed by NCI CTCAE v4.0 [ Designated as safety issue: Yes ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
- 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.
- 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.
- 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.