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Sponsors and Collaborators: |
Princess Margaret Hospital, Canada National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00691730 |
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 |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: aflibercept Drug: bevacizumab Drug: cediranib maleate Drug: sunitinib malate Procedure: immunoenzyme technique Procedure: laboratory biomarker analysis Procedure: 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 |
Estimated Enrollment: | 90 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Planning to start treatment with one of the following antiangiogenic drugs as single agents or in combination with chemotherapy for their cancer:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 |
Study Chair: | Malcolm J. Moore, MD | Princess Margaret Hospital, Canada |
Study ID Numbers: | CDR0000588665, PMH-PHL-064 |
Study First Received: | June 4, 2008 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00691730 |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific |
Sunitinib Bevacizumab |
Antineoplastic Agents Therapeutic Uses Growth Substances Physiological Effects of Drugs |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |