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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 4, 2008

Last Updated Date

February 6, 2009

Start Date ^†

February 2008

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00691730 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

The Role of VEGF-A Signaling in Maintenance of the Glomerular Filtration Barrier and Blood Pressure

Brief Summary

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.

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label

Condition ^†

Unspecified Adult Solid Tumor, Protocol Specific

Intervention ^†

Biological: aflibercept
Biological: bevacizumab
Drug: cediranib maleate
Drug: sunitinib malate
Other: immunoenzyme technique
Other: laboratory biomarker analysis
Other: pharmacological study

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Completion Date

Estimated Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00691730

Responsible Party

Secondary IDs ^††

PMH-PHL-064

Study Sponsor ^†

Princess Margaret Hospital, Canada

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Study Chair:

Malcolm J. Moore, MD

Princess Margaret Hospital, Canada

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.