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OpenTrials
Completed

NCT Number: NCT00929058

Bevacizumab and Vasoconstriction

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.

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Key information

Conditions

Hypertension Cancer Cardiovascular Diseases Neoplasms Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

Intra-arterial infusion during 6 minutes

Primary outcomes

  1. 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

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

    Time frame: Infusion of bevacizumab during 6 minutes

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: BVZ1

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 26, 2009
Registry last updated
May 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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