NCT01096381

Potential Biomarkers for Bevacizumab-Induced High Blood Pressure in Patients With Solid Tumor

A Prospective Clinical Trial Evaluating Potential Biomarkers for Bevacizumab Induced Hypertension

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Studying samples of blood and urine in the laboratory from patients with cancer receiving bevacizumab may help doctors learn more about changes that occur in DNA and identify biomarkers related to high blood pressure. PURPOSE: This phase I trial is studying potential biomarkers for bevacizumab-induced high blood pressure in patients with malignant solid tumors, including breast cancer, colorectal cancer, non-small cell lung cancer, head and neck cancer, ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma.

Detailed description

OBJECTIVES: Primary * 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 bevacizumab. * To compare endothelial function changes between patients who develop hypertension (HTN) versus patients who do not develop HTN. Secondary * 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 patients. * 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.

Conditions

• Breast Cancer
• Cardiovascular Complications
• Colorectal Cancer
• Fallopian Tube Cancer
• Head and Neck Cancer
• Lung Cancer
• Ovarian Cancer
• Peritoneal Cavity Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis	Blood collection
OTHER	questionnaire administration	Survey regarding baseline health and activity level.

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-07-01
• Completion: 2011-08-01
• First posted: 2010-03-31
• Last updated: 2012-02-27

Locations

2 sites across 1 country: United States