Stage III Pancreatic Cancer Clinical Trial
Official title:
Phase IIA Trial Testing Erlotinib as an Intervention Against Intraductal Pancreatic Mucinous Neoplasms
Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. This phase II trial is studying how well erlotinib hydrochloride works in treating patients with pancreatic cancer that can be removed by surgery
PRIMARY OBJECTIVES:
I. To test the hypothesis that the activated epidermal growth factor receptor (EGFR) signal
transduction biomarker Mucin 5AC (MUC5AC) protein expression within intraductal pancreatic
mucinous neoplasm (IPMN) lesions will have greater than zero absolute mean decrease from
baseline comparing pre and post 21-42 days of Erlotinib (erlotinib hydrochloride)
administration at 100mg orally (PO) once daily (QD).
SECONDARY OBJECTIVES:
I. To test the hypothesis that other correlative IPMN EGF inducible biomarkers will have
greater than zero absolute mean decrease from baseline pre and post Erlotinib 100mg PO QD
therapy.
II. Safety of Erlotinib treatment. III. To determine Erlotinib pharmacokinetic concentration
in plasma and pancreatic tissue at the 100mg/day dose up to 42 days of therapy.
OUTLINE:
Patients receive erlotinib hydrochloride PO QD for 21-42 days in the absence of disease
progression or unacceptable toxicity. Patients then undergo to pancreatectomy.
After completion of study treatment, patients are followed up at 4-20 weeks.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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