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NCI 8076: Kidney and Blood Pressure Changes in Patients Receiving Bevacizumab, Aflibercept, Sunitinib, or Cediranib for Cancer

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT00691730
Collaborator
National Cancer Institute (NCI) (NIH)
52
Enrollment
4
Locations
133.9
Actual Duration (Months)
13
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: laboratory biomarker analysis

Detailed Description

OBJECTIVES:

  1. To study the renal and blood pressure changes in patients treated with bevacizumab, aflibercept, sunitinib malate, or cediranib for their cancer.

  2. 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).

  3. 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.

Study Design

Study Type:
Observational
Actual Enrollment :
52 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
The Role of VEGF-A Signaling in Maintenance of the Glomerular Filtration Barrier and Blood Pressure
Actual Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Apr 1, 2019

Outcome Measures

Primary Outcome Measures

  1. Renal and blood pressure changes [Up to 8 weeks]

  2. Physiological mechanism behind proteinuria and hypertension induced by antiangiogenic therapies [Up to 8 weeks]

  3. Predictive value of soluble factors in the development of proteinuria or hypertension [Up to 8 weeks]

  4. Predictive value of steady state drug concentrations in the development of proteinuria or hypertension [Up to 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tom Baker Cancer Centre Calgary Alberta Canada T2N 4N2
2 London Regional Cancer Program London Ontario Canada N6A 4L6
3 Mount Sinai Hospital Toronto Ontario Canada M5G 1X5
4 University Health Network-Princess Margaret Hospital Toronto Ontario Canada M5G 2M9

Sponsors and Collaborators

  • University Health Network, Toronto
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Malcolm Moore, University Health Network-Princess Margaret Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00691730
Other Study ID Numbers:
  • PHL-064
  • NCI-2009-00277
  • PMH-PHL-064
  • CDR0000588665
First Posted:
Jun 5, 2008
Last Update Posted:
Jan 27, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 27, 2021