Bevacizumab and Vasoconstriction

Radboud University Medical Center10 enrolled

Overview

Rationale: The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most common side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab hypertension had an overall incidence up to 32%. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear. Objective: To study if arterial bevacizumab infusion causes acute vasoconstriction using plethysmography in healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Hypertension Cancer

Interventions

BevacizumabDRUG

Intra-arterial infusion during 6 minutes

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male 18-50 years old * normal results of glucose, lipids and creatinine * informed consent Exclusion Criteria: * History of abuse of drugs or alcohol * History of malignant disease * First degree relatives with a history of cancer before the age of 50 * First degree relatives with a history of premature cardiovascular disease * Current use of medication * Clinical evidence of cardiac of pulmonary disease * Hypertension ( systolic\>140mmHg, diastolic \>90mmHg) * Diabetes mellitus * smoking * a history of thombosis or a family history of recurrent thrombosis * abnormality on ECG

Locations (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Outcomes

Primary Outcomes

Fore-arm vasomotor response to administered bevacizumab, expressed as percentage change in forearm blood flow ratio

Time frame: Infusion of bevacizumab during 6 minutes

Secondary Outcomes

Correlation between VEGF concentrations in plasma and the vasoconstrictive response to bevacizumab

Time frame: Infusion of bevacizumab during 6 minutes

Data from ClinicalTrials.gov

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