Stage IV Pancreatic Cancer Clinical Trial
Official title:
Cancer Stem Cells and Inhibition of Hedgehog Pathway Signaling in Advanced Pancreas Cancer: A Pilot Study of GDC-0449 in Combination With Gemcitabine
This pilot clinical trial studies vismodegib and gemcitabine hydrochloride in treating patients with advanced pancreatic cancer. Vismodegib may stop the growth of pancreatic cancer by blocking blow flow to the tumor. Gemcitabine hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vismodegib and gemcitabine hydrochloride may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To obtain tumor biopsies before and after therapy with GDC-0449 (vismodegib) to evaluate
the effect of inhibition of hedgehog signaling on pancreatic cancer stem cells by: evaluating
the tumor for number and percentage of pancreatic cancer stem cells before and after
treatment with GDC-0449.
SECONDARY OBJECTIVES:
I. To assess progression free survival (PFS) at 3 months following treatment with GDC-0449
and gemcitabine (gemcitabine hydrochloride).
II. To assess response rate to treatment and overall survival in patients with advanced
pancreas cancer treated with GDC-0449 alone and in combination with gemcitabine.
III. To evaluate the toxicity of GDC-0449 alone and in combination with gemcitabine.
OUTLINE:
Patients receive vismodegib orally (PO) once daily (QD) on days 1-28 and gemcitabine
hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15 (beginning in course
2). Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
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