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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00691730
First Posted: June 5, 2008
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University Health Network, Toronto
June 4, 2008
June 5, 2008
November 8, 2017
February 2008
June 2012   (Final data collection date for primary outcome measure)
  • Renal and blood pressure changes [ Time Frame: Up to 8 weeks ]
  • Physiological mechanism behind proteinuria and hypertension induced by antiangiogenic therapies [ Time Frame: Up to 8 weeks ]
  • Predictive value of soluble factors in the development of proteinuria or hypertension [ Time Frame: Up to 8 weeks ]
  • Predictive value of steady state drug concentrations in the development of proteinuria or hypertension [ Time Frame: Up to 8 weeks ]
  • Renal and blood pressure changes
  • Physiological mechanism behind proteinuria and hypertension induced by antiangiogenic therapies
  • Predictive value of soluble factors in the development of proteinuria or hypertension
  • Predictive value of steady state drug concentrations in the development of proteinuria or hypertension
Complete list of historical versions of study NCT00691730 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Unspecified Adult Solid Tumor, Protocol Specific
  • Other: laboratory biomarker analysis
    Correlative studies
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
Arm I
To analyze proteinuria/hypertension with anti-angiogenic therapies, specifically Bevacizumab, AZD2171, Sunitinib and VEGF Trap. 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. Analyses will be considered purely exploratory and no testing will be performed for difference between treatments.
Interventions:
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2018
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00691730
PHL-064
NCI-2009-00277 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
PMH-PHL-064
CDR0000588665 ( Registry Identifier: PDQ (Physician Data Query) )
Not Provided
Not Provided
Not Provided
University Health Network, Toronto
University Health Network, Toronto
National Cancer Institute (NCI)
Principal Investigator: Malcolm Moore University Health Network-Princess Margaret Hospital
University Health Network, Toronto
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP