Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Measuring Effects of Pazopanib Hydrochloride in Patients With Metastatic Kidney Cancer
The purpose of this study is to find out what effects pazopanib (pazopanib hydrochloride) (also called Votrient®) may have on MRI (magnetic resonance imaging) scans, blood pressure, and various proteins in the blood. Pazopanib is Food and Drug Administration (FDA) approved for treating renal cell cancer. It is an agent that prevents angiogenesis, which is new blood vessel formation. The use of pazopanib described in this study is a standard of care, but the additional MRI and blood tests that will be performed are experimental
Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Drug: pazopanib hydrochloride
Other: laboratory biomarker analysis
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Other: pharmacogenomic studies
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||DCE-MRI as Pazopanib Biomarker in Metastatic Renal Cancer|
- Disease progression based on change in K^trans rise from nadir as assessed by the method described in Donner [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Cox proportional hazards model incorporating a baseline clinical prognostic index (good/intermediate/poor) and prior VEGF pathway inhibitor therapy (yes/no) as covariates will be assessed.
- Changes in blood pressure and sVEGFR2 as a pazopanib hydrochloride biomarkers [ Time Frame: Baseline to 1 week post-treatment ] [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (pazopanib hydrochloride, DCE-MRI)
Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.
Drug: pazopanib hydrochloride
Other Names:Other: laboratory biomarker analysis
Correlative studiesProcedure: dynamic contrast-enhanced magnetic resonance imaging
Undergo dynamic contrast-enhanced magnetic resonance imaging
Other Name: DCE-MRIOther: pharmacogenomic studies
Other Name: Pharmacogenomic Study
I. To determine whether a K^trans rise from nadir is predictive of subsequent tumor growth.
I. To determine the association between changes in mean ambulatory blood pressure measurements, K^trans, and tumor size changes with pazopanib therapy.
II. To determine the association between changes in soluble vascular endothelial growth factor receptor 2 (sVEGFR2) measurements, K^trans, and tumor size changes with pazopanib therapy.
I. To explore previously described single nucleotide polymorphisms (SNP's) as pharmacogenomic biomarkers.
II. To model tumor growth kinetics using radiologic tumor size measurements. III. To explore other serum and plasma based putative biomarkers of vascular endothelial growth factor (VEGF) pathway inhibition.
Patients receive pazopanib hydrochloride orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01599832
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center||Recruiting|
|Chicago, Illinois, United States, 60637-1470|
|Contact: Walter M. Stadler 773-702-4400 email@example.com|
|Principal Investigator: Walter M. Stadler|
|Principal Investigator:||Walter Stadler||University of Chicago Comprehensive Cancer Center|