RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bavituximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel together with bavituximab may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects of giving paclitaxel and bavituximab together in treating patients with Human Epidermal growth factor Receptor 2 (HER2 )-negative metastatic breast cancer
PRIMARY OBJECTIVES: I. To determine the safety, feasibility, and tolerability of combining paclitaxel with weekly bavituximab therapy. SECONDARY OBJECTIVES: I. To describe changes in pharmacodynamic markers and coagulation markers in response to single agent and combined therapy. OUTLINE: Patients receive paclitaxel intravenously (IV) on days 1, 8, and 15 and bavituximab IV on days 1, 8, 15, and 22 (days 15 and 22 only of course 1). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Arizona Cancer Center
Tucson, Arizona, United States
Determination of grade 3 or higher toxicities associated with the combination therapy as classified using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: One year
Overall response rate of the regimen by RECIST
Time frame: One year
Progression free survival (PFS)
Time frame: One year
Measurable changes in levels of circulating endothelial cells (CEC), circulating endothelial progenitors (CEP), apoptotic CEC, and circulating tumor cells (CTC), as well as changes in cell-specific microparticle formation in response to therapy
Time frame: One year
Activation of coagulation as measured by changes in D-dimer levels and platelet activation markers in response to therapy
Time frame: One year
Collection and storage of additional plasma for further analysis of angiogenic markers (i.e., VCAM and VEGF)
Time frame: One year
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