NCT00691730

Kidney and Blood Pressure Changes in Patients Receiving Bevacizumab, Aflibercept, Sunitinib, or Cediranib for Cancer

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is looking at kidney and blood pressure changes in patients receiving bevacizumab, aflibercept, sunitinib, or cediranib for cancer. Studying samples of blood and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment with an antiangiogenic drug.

Detailed description

OBJECTIVES: 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 hypertension). 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 proteinuria/hypertension. 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 levels.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis	Only sample collection, no other intervention - Correlative studies

Timeline

• Start date: 2008-02-01
• Primary completion: 2012-07-01
• Completion: 2019-04-01
• First posted: 2008-06-05
• Last updated: 2021-01-27

Locations

4 sites across 1 country: Canada