Paclitaxel and Bavituximab in Treating Patients With HER2-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
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Male Breast Cancer
Recurrent Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of Weekly Paclitaxel in Combination With Bavituximab in Patients With Her-2 Negative Metastatic Breast Cancer|
- 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 ] [ Designated as safety issue: Yes ]
- Overall response rate of the regimen by RECIST [ Time Frame: One year ] [ Designated as safety issue: No ]
- Progression free survival (PFS) [ Time Frame: One year ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Activation of coagulation as measured by changes in D-dimer levels and platelet activation markers in response to therapy [ Time Frame: One year ] [ Designated as safety issue: No ]
- Collection and storage of additional plasma for further analysis of angiogenic markers (i.e., VCAM and VEGF) [ Time Frame: One year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Study Completion Date:||July 2015|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Paclitaxel, bavituximab, laboratory biomarker analysis and pharmacological study
Other Names:Biological: bavituximab
Other Name: TarvacinOther: laboratory biomarker analysis
Correlative studiesOther: pharmacological study
Other Name: pharmacological studies
I. To determine the safety, feasibility, and tolerability of combining paclitaxel with weekly bavituximab therapy.
I. To describe changes in pharmacodynamic markers and coagulation markers in response to single agent and combined therapy.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288261
|United States, Arizona|
|Arizona Cancer Center|
|Tucson, Arizona, United States, 85724-5024|
|Principal Investigator:||Alison Stopeck||University of Arizona|