Stage IV Breast Cancer Clinical Trial
Official title:
A Phase I Trial of Weekly Paclitaxel in Combination With Bavituximab in Patients With Her-2 Negative Metastatic Breast Cancer
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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