Overview

This trial is active, not recruiting.

Condition unspecified adult solid tumor, protocol specific
Treatments laboratory biomarker analysis, pharmacological study
Sponsor University Health Network, Toronto
Collaborator National Cancer Institute (NCI)
Start date February 2008
End date June 2012
Trial size 60 participants
Trial identifier NCT00691730, CDR0000588665, NCI-2009-00277, PHL-064, PMH-PHL-064

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
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.
laboratory biomarker analysis
Correlative studies
pharmacological study pharmacological studies
Correlative studies

Primary Outcomes

Measure
Renal and blood pressure changes
time frame: Not Provided
Physiological mechanism behind proteinuria and hypertension induced by antiangiogenic therapies
time frame: Not Provided
Predictive value of soluble factors in the development of proteinuria or hypertension
time frame: Not Provided
Predictive value of steady state drug concentrations in the development of proteinuria or hypertension
time frame: Not Provided

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Role of VEGF-A Signaling in Maintenance of the Glomerular Filtration Barrier and Blood Pressure
Principal investigator Malcolm Moore
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.