Bevacizumab and Endothelium Dependent Vasodilation

NCT ID: NCT01125943

Last Updated: 2013-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-11-30

Brief Summary

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.

Conditions

Hypertension; Cancer; Endothelial Dysfunction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Acetylcholine

Intra-arterial infusion of acetylcholine in two increasing dosages during 5 minutes each during the intra-arterial infusion of bevacizumab

Group Type: EXPERIMENTAL

Acetylcholine

Intervention Type: DRUG

Intra-arterial infusion

Bevacizumab

Intervention Type: DRUG

Intra arterial infusion

Nitroprusside

Infusion of two increasing dosages of nitroprusside during 5 minutes each during the continuous infusion of bevacizumab

Group Type: EXPERIMENTAL

Nitroprusside

Intervention Type: DRUG

Intra arterial infusion

Bevacizumab

Intervention Type: DRUG

Intra arterial infusion

Interventions

Acetylcholine

Intra-arterial infusion

Intervention Type: DRUG

Nitroprusside

Intra arterial infusion

Intervention Type: DRUG

Bevacizumab

Intra arterial infusion

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dutch Cancer Society

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

G. Rongen

Prof dr. G. Rongen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Countries

Netherlands

Other Identifiers

BVZAch

Identifier Type: -

Identifier Source: org_study_id