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

Sponsor:	Princess Margaret Hospital, Canada
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00691730

Purpose

RATIONALE: 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.

PURPOSE: This research study is looking at kidney and blood pressure changes in patients receiving bevacizumab, aflibercept, sunitinib, or cediranib for cancer.

Condition	Intervention
Unspecified Adult Solid Tumor, Protocol Specific	Biological: aflibercept Biological: bevacizumab Drug: cediranib maleate Drug: sunitinib malate Other: immunoenzyme technique Other: laboratory biomarker analysis Other: pharmacological study

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	The Role of VEGF-A Signaling in Maintenance of the Glomerular Filtration Barrier and Blood Pressure

Resource links provided by NLM:

MedlinePlus related topics: Cancer High Blood Pressure

Drug Information available for: Bevacizumab Cediranib Sunitinib malate Sunitinib Aflibercept

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 ]

Estimated Enrollment:	90
Study Start Date:	February 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

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

After completion of study treatment, patients are followed at 4 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Urinalysis negative for protein OR 24-hour urine for protein < 500 mg

PRIOR CONCURRENT THERAPY:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691730

Locations

Canada, Alberta
Tom Baker Cancer Centre - Calgary	Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Patricia Tang 403-521-3707
Canada, Ontario
Mount Sinai Hospital - Toronto	Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Susan Quaggin 416-586-4800
Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Malcolm J. Moore, MD 416-946-2263

Sponsors and Collaborators

Princess Margaret Hospital, Canada

National Cancer Institute (NCI)

Investigators

Study Chair:

Malcolm J. Moore, MD

Princess Margaret Hospital, Canada

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000588665, PMH-PHL-064
Study First Received:	June 4, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00691730 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Antineoplastic Agents
Sunitinib
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs

Growth Inhibitors
Angiogenesis Modulating Agents
Bevacizumab
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2009