A Phase II Study of BAY 43-9006/Gemcitabine for Advanced Pancreatic Cancer
I. Determine the objective response rate in patients with locally advanced or metastatic
adenocarcinoma of the pancreas treated with sorafenib and gemcitabine.
II. Determine the toxicity experienced by patients with advanced pancreatic cancer who are
treated with sorafenib plus gemcitabine.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28 and gemcitabine IV over 30 minutes
on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 7 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate as measured by RECIST criteria
Up to 6 months
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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