A Prospective Clinical Trial Evaluating Potential Biomarkers for Bevacizumab Induced Hypertension
- To measure the endothelial function over time, including non-invasive assessment of
digital-pulse amplitude via Endo-pat test, serum tPA, PAI-1, VEGF, urine TXa2, and
PGI-M, in patients with solid malignancies treated with chemotherapy with or without
- To compare endothelial function changes between patients who develop hypertension (HTN)
versus patients who do not develop HTN.
- To compare circulating soluble cytokines, proangiogenic factors, glucose tolerance, and
cardiac biomarkers over time in these patients.
- To compare endothelial progenitor cell levels pre- and post-bevacizumab in these
- To assess whether physical fitness level at baseline and at 3 months after treatment
initiation (assessed subjectively by questionnaire) correlates with relative risk of
developing NCI grade ≥ I cardiotoxicity.
OUTLINE: Patients undergo 24-hour blood pressure monitoring at baseline, before second
bevacizumab therapy, and periodically during study. Patients also undergo a digital-pulse
amplitude measurement periodically during study.
Blood samples are collected at baseline and periodically during study for circulating
soluble cytokines, proangiogenic factors, glucose tolerance, cardiac biomarkers, and
endothelial progenitor cell level studies. Patients also undergo 24-hour urine sample
collection at baseline and periodically during study for protein, creatinine, and
metabolites of prostacyclin and thromboxane.
Patients complete physical activity questionnaires at baseline and at 3 months.
Observational Model: Cohort, Time Perspective: Prospective
Digital-pulse amplitude (DPA) measures
1, 3 and 6 months after initiation of bevacizumab
Ingrid Mayer, M.D.
Vanderbilt-Ingram Cancer Center
United States: Vanderbilt University Human Research Protection Program
VICC BRE 0983
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Nashville, Tennessee 37064|