Kidney and Blood Pressure Changes in Patients Receiving Bevacizumab, Aflibercept, Sunitinib, or Cediranib for Cancer
NCI 8076
The Role of VEGF-A Signaling in Maintenance of the Glomerular Filtration Barrier and Blood Pressure
4 other identifiers
observational
52
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2008
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 4, 2008
CompletedFirst Posted
Study publicly available on registry
June 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedJanuary 27, 2021
January 1, 2021
4.4 years
June 4, 2008
January 25, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
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
Interventions
Only sample collection, no other intervention - Correlative studies
Eligibility Criteria
Patients who are going to start treatment with bevacizumab, VEGF Trap, sunitinib or AZD2171.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Malcolm Moore
University Health Network-Princess Margaret Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2008
First Posted
June 5, 2008
Study Start
February 1, 2008
Primary Completion
July 1, 2012
Study Completion
April 1, 2019
Last Updated
January 27, 2021
Record last verified: 2021-01