Biomarker and Clinical Evaluation of Bevacizumab (Avastin) to Determine the Role of Nitric Oxide in Anti-VEGF Therapy
OBJECTIVES:
Primary
- Determine whether anti-vascular epidermal growth factor (VEGF) treatment comprising
bevacizumab causes changes in endothelial cell function, as measured by brachial
reactivity, and changes in nitric oxide (NOx), as measured by plasma/urinary/exhaled
NOx levels, in patients with advanced solid tumors.
- Determine whether anti-VEGF-related changes in blood pressure correlate with changes in
brachial reactivity and NOx levels.
Secondary
- Evaluate anti-angiogenic effects of bevacizumab in neovascular tissue in the wound
angiogenesis model.
- Correlate inhibition of wound angiogenesis with changes in VEGF-receptor 2
phosphorylation status and changes in NOx synthase expression.
- Describe the mean and associated variability of other plasma and urine markers known to
be associated with vascular reactivity, endothelial function, and/or tumor
angiogenesis.
- Describe, preliminarily, whether these changes correlate with changes in blood
pressure, brachial reactivity, NOx levels, or wound angiogenesis.
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29. After the
third dose of bevacizumab, patients may receive additional bevacizumab in combination with
chemotherapy in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Herbert I. Hurwitz, MD
Principal Investigator
Duke Cancer Institute
United States: Food and Drug Administration
Pro00008011
NCT00416637
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