A Phase II Study of BAY 43-9006/Gemcitabine for Advanced Pancreatic Cancer
PRIMARY OBJECTIVES:
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
unacceptable toxicity.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 7 months.
Interventional
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
No
Hedy Kindler
Principal Investigator
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
NCI-2012-02629
NCT00095966
September 2004
Name | Location |
---|---|
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |