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The Role of VEGF-A Signaling in Maintenance of the Glomerular Filtration Barrier and Blood Pressure

18 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

The Role of VEGF-A Signaling in Maintenance of the Glomerular Filtration Barrier and Blood Pressure


I. To study the renal and blood pressure changes in patients treated with bevacizumab,
aflibercept, sunitinib malate, or cediranib for their cancer.

II. To determine the physiological mechanisms behind proteinuria and hypertension induced by
antiangiogenic therapies (i.e., rarefaction; imbalance in eNOS, prostacyclin [PGI_2],
prostaglandin E2 [PGE_2], and thromboxane A2 [TXA2]; renin/aldosterone; or renovascular

III. To determine whether soluble factors (like tyrosine kinase 1 [sFlt1], bFGF, and VEGF)
and steady state drug concentration are predictive of the development of

OUTLINE: This is a multicenter study.

Patients undergo blood and urine sample collection periodically. Urine samples are assessed
for PGI2 and TXA2 levels using validated ELISA methods. Urine is also assessed for protein
and creatinine levels, microalbumin, osmolality, and electrolytes. Blood samples are
assessed for pharmacokinetics and sFlt1, VEGF, and bFGF levels by validated ELISA methods.
Blood samples are also assessed for steady state drug concentration, renin, and aldosterone

Inclusion Criteria:

- Planning to start treatment with one of the following antiangiogenic drugs as single
agents or in combination with chemotherapy for their cancer:

- Cediranib

- Bevacizumab

- Sunitinib malate

- Aflibercept

- Urinalysis negative for protein OR 24-hour urine for protein < 500 mg

- Prior chemotherapy within the past 12 months allowed

- More than 12 months since prior antiangiogenic drugs, including monoclonal antibodies
that bind to VEGF or tyrosine kinase inhibitors that block VEGFR2

- At least 6 weeks since prior and no concurrent aldosterone receptor antagonists
(e.g., spironolactone [aldactone] or eplerenone)

- No other concurrent investigational agents

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Renal and blood pressure changes

Outcome Time Frame:

Not Provided

Safety Issue:


Principal Investigator

Malcolm Moore

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network-Princess Margaret Hospital


United States: Institutional Review Board

Study ID:




Start Date:

February 2008

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific