Stage IV Pancreatic Cancer Clinical Trial
Official title:
A Phase II Study of BAY 43-9006/Gemcitabine for Advanced Pancreatic Cancer
Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib with gemcitabine may kill more tumor cells. This phase II trial is studying how well giving sorafenib together with gemcitabine works in treating patients with locally advanced or metastatic 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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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