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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00691730
First received: June 4, 2008
Last updated: May 10, 2013
Last verified: May 2013

June 4, 2008
May 10, 2013
February 2008
January 2100   (final data collection date for primary outcome measure)
  • Renal and blood pressure changes [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
  • Physiological mechanism behind proteinuria and hypertension induced by antiangiogenic therapies [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
  • Predictive value of soluble factors in the development of proteinuria or hypertension [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
  • Predictive value of steady state drug concentrations in the development of proteinuria or hypertension [ Time Frame: Not Provided ] [ Designated as safety issue: Yes ]
  • Renal and blood pressure changes [ Designated as safety issue: No ]
  • Physiological mechanism behind proteinuria and hypertension induced by antiangiogenic therapies [ Designated as safety issue: No ]
  • Predictive value of soluble factors in the development of proteinuria or hypertension [ Designated as safety issue: No ]
  • Predictive value of steady state drug concentrations in the development of proteinuria or hypertension [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00691730 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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: 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
Active Comparator: Arm I
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:
  • 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
Not Provided
January 2100   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00691730
NCI-2009-00277, PHL-064, PMH-PHL-064, CDR0000588665
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Malcolm Moore University Health Network-Princess Margaret Hospital
National Cancer Institute (NCI)
May 2013

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