Bevacizumab and Endothelium Dependent Vasodilation

January 8, 2013 updated by: G. Rongen, Radboud University Medical Center

The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most reported side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab, a monoclonal antibody against vascular endothelial growth factor, hypertension had an overall incidence up to 32%. The increase in blood pressure occurs early in treatment. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear. Understanding the pathogenesis of this side effect is essential for optimal treatment with this class of drugs.

The primary objective is to explore the effect of bevacizumab infusion on endothelium-dependent vasodilation of forearm resistance arteries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands
        • Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Age 18-50 years old
  2. Male
  3. Results of serum glucose, lipids and creatinine should be within the laboratory's reference ranges.
  4. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.

Exclusion Criteria:

  1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
  2. History of or current abuse of drugs, alcohol or solvents.
  3. History of malignant disease.
  4. First degree relatives with a history of cancer before the age of 50
  5. First degree relatives with a history of premature cardiovascular disease before the age of 50
  6. Current use of medication.
  7. Clinical evidence of cardiac or pulmonary disease
  8. Hypertension ( systole >140mmHG, diastole >90mmHg)
  9. Diabetes mellitus
  10. Smoking
  11. Any clinically relevant abnormality on ECG.
  12. A history of thrombosis or first degree family members with a history of recurrent thrombosis
  13. Inability to understand the nature and extent of the trial and the procedures required.
  14. Previous participation in a study with bevacizumab

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acetylcholine
Intra-arterial infusion of acetylcholine in two increasing dosages during 5 minutes each during the intra-arterial infusion of bevacizumab
Drug: Acetylcholine
Intra-arterial infusion
Drug: Bevacizumab
Intra arterial infusion
Experimental: Nitroprusside
Infusion of two increasing dosages of nitroprusside during 5 minutes each during the continuous infusion of bevacizumab
Drug: Bevacizumab
Intra arterial infusion
Drug: Nitroprusside
Intra arterial infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vasomotor response assessed by venous occlusion strain gauge plethysmography
Time Frame: 15 minutes
Response to infusion of bevacizumab and/or acetylcholin or nitroprusside
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Dutch Cancer Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

May 17, 2010

First Posted (Estimate)

May 19, 2010

Study Record Updates

Last Update Posted (Estimate)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BVZAch

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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