Rationale: Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment. Purpose: This clinical trial is studying MRI in predicting response to sunitinib malate in patients with locally advanced or metastatic kidney cancer.
Primary Objectives: I. To correlate tumor vascular permeability by DCE-MRI with clinical outcome for patients treated with sunitinib (PFS). II. To correlate genetic and histologic characteristics of the primary tumor with vascular permeability by DCE-MRI. Secondary Objectives: I. To correlate genetic and histologic characteristics of the primary tumor with clinical outcome for patients treated with sunitinib. II. Samples will be collected for potential future exploratory analyses of pharmacokinetic and pharmacogenomic parameters. Outline: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of sunitinib malate.
Study Type
OBSERVATIONAL
Enrollment
43
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States
Progression-free survival
Correlation of tumor vascular permeability as measured by dynamic contrast-enhanced MRI with clinical outcome and with tumor angiogenesis as measured by immunohistochemistry (IHC)
Tumor regression as measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
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Given orally
Correlative study
Correlative study