Pancreatic Cancer Clinical Trial
Official title:
Phase II Study of Gemcitabine and Intermittent Erlotinib in Advanced Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
growth. Giving gemcitabine together with erlotinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with erlotinib
works in treating patients with metastatic or recurrent pancreatic cancer.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15 and oral erlotinib
hydrochloride on days 2-5, 9-12, and 16-26. Treatment repeats every 28 days for up to 1 year
in the absence of disease progression or unacceptable toxicity.
Archived tumor tissue samples are analyzed for the expression of EGFR, HER3, HER2, downstream
signaling molecules, and other molecular markers by immunohistochemistry and RT-PCR. The
presence of aberrant gene copy numbers (amplification and polysomy) for EGFR, HER3, and HER2
are determined by FISH. Blood samples are collected at baseline and periodically during study
for polymorphism analysis and correlative molecular analysis of surrogate endpoint
biomarkers.
After completion of study therapy, patients are followed every 3 months.
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