Phase IIA Trial Testing Erlotinib as an Intervention Against Intraductal Pancreatic Mucinous Neoplasms
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).
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
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.
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
Greater than zero absolute mean decrease in MUC5AC expression
This measurement is a continuous variable. A single group univariate repeated measures analysis of variance will be used to detect differences over time in biomarker expression. Changes over time will be tested using univariate analysis of variance for repeated measures.
Chao Family Comprehensive Cancer Center
United States: Food and Drug Administration
|University of California Medical Center At Irvine-Orange Campus||Orange, California 92868|