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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00691730

Acronym

NCI 8076

Enrollment

Registered

2008-06-05

Start date

2008-02-29

Completion date

2019-04-30

Last updated

2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Brief 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.

Interventions

OTHERlaboratory biomarker analysis

Only sample collection, no other intervention - Correlative studies

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 (AZD2171 ) * Bevacizumab (Avastin) * Sunitinib (Sutent) * Aflibercept (VEGF Trap) * 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

Design outcomes

Primary

Measure	Time frame
Renal and blood pressure changes	Up to 8 weeks
Physiological mechanism behind proteinuria and hypertension induced by antiangiogenic therapies	Up to 8 weeks
Predictive value of soluble factors in the development of proteinuria or hypertension	Up to 8 weeks
Predictive value of steady state drug concentrations in the development of proteinuria or hypertension	Up to 8 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026