Renal Cell Carcinoma Clinical Trial
Official title:
An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic or Locally Advanced Renal Cell Carcinoma
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.
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