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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00277 | Other Identifier | CTRP (Clinical Trials Reporting System) | |
| PMH-PHL-064 | |||
| CDR0000588665 | Registry Identifier | PDQ (Physician Data Query) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other | Only sample collection, no other intervention - Correlative studies |
| Measure | Description | Time Frame |
|---|---|---|
| Renal and blood pressure changes | Up to 8 weeks | |
| Physiological mechanism behind proteinuria and hypertension induced by antiangiogenic therapies | Up to 8 weeks | |
| Predictive value of soluble factors in the development of proteinuria or hypertension | Up to 8 weeks | |
| Predictive value of steady state drug concentrations in the development of proteinuria or hypertension | Up to 8 weeks |
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Inclusion Criteria:
Planning to start treatment with one of the following antiangiogenic drugs as single agents or in combination with chemotherapy for their cancer:
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
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Patients who are going to start treatment with bevacizumab, VEGF Trap, sunitinib or AZD2171.
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| Name | Affiliation | Role |
|---|---|---|
| Malcolm Moore | University Health Network-Princess Margaret Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada | ||
| London Regional Cancer Program |
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| London |
| Ontario |
| N6A 4L6 |
| Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| University Health Network-Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |