An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic or Locally Advanced Renal Cell Carcinoma
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Progression-free survival
No
Stephen Keefe
Principal Investigator
Abramson Cancer Center of the University of Pennsylvania
United States: Institutional Review Board
UPCC 03809
NCT01026337
April 2009
April 2013
Name | Location |
---|---|
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |