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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Given orally
Given IV
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Response rate as measured by RECIST criteria
Time frame: Up to 6 months
Progression free survival
Kaplan-Meier curves will be constructed.
Time frame: From start of treatment to progression or death, assessed up to 6 months
Survival
Specific attention will be given to the six-month survival rate, for which 90% confidence intervals will be generated.
Time frame: At 6 months
Overall survival
Kaplan-Meier curves will be constructed
Time frame: Up to 6 months
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