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

NCT ID: NCT00691730

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2019-04-30

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.

Detailed Description

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

laboratory biomarker analysis

Only sample collection, no other intervention - Correlative studies

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malcolm Moore

Role: PRINCIPAL_INVESTIGATOR

University Health Network-Princess Margaret Hospital

Locations

Tom Baker Cancer Centre

Calgary, Alberta, Canada

London Regional Cancer Program

London, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

NCI-2009-00277

Identifier Type: OTHER

Identifier Source: secondary_id

PMH-PHL-064

Identifier Type: -

Identifier Source: secondary_id

CDR0000588665

Identifier Type: REGISTRY

Identifier Source: secondary_id

PHL-064

Identifier Type: -

Identifier Source: org_study_id