NCT01599832

Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Measuring Effects of Pazopanib Hydrochloride in Patients With Metastatic Kidney Cancer

DCE-MRI as Pazopanib Biomarker in Metastatic Renal Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

PRIMARY OBJECTIVES: I. To determine whether a K\^trans rise from nadir is predictive of subsequent tumor growth. SECONDARY OBJECTIVES: 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. TERTIARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

• Clear Cell Renal Cell Carcinoma
• Recurrent Renal Cell Cancer
• Stage IV Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	pazopanib hydrochloride	Given PO
OTHER	laboratory biomarker analysis	Correlative studies
PROCEDURE	dynamic contrast-enhanced magnetic resonance imaging	Undergo dynamic contrast-enhanced magnetic resonance imaging
OTHER	pharmacogenomic studies	Correlative studies

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-05-16
• Last updated: 2017-06-08
• Results posted: 2017-06-08

Locations

4 sites across 1 country: United States