Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
Intraductal Papillary Mucinous Neoplasm of the Pancreas
Recurrent Pancreatic Cancer
Stage IA Pancreatic Cancer
Stage IB Pancreatic Cancer
Stage IIA Pancreatic Cancer
Stage IIB Pancreatic Cancer
Stage III Pancreatic Cancer
Drug: erlotinib hydrochloride
Procedure: conventional surgery
Other: immunohistochemistry staining method
Genetic: protein expression analysis
Other: pharmacological study
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase IIA Trial Testing Erlotinib as an Intervention Against Intraductal Pancreatic Mucinous Neoplasms|
- Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment [ Time Frame: Pre-treatment and post-treatment ] [ Designated as safety issue: No ]Number of participants showed a reduction in number of positive IPMN cells and staining intensity after treatment
- Plasma Calculated Concentration - OSI-774 (ng/mL) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]Plasma concentration levels of Erlotinib (OSI-774)
- Pancreas Calculated Concentration - OSI-774 (ng/g) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]Pancreatic tissue concentration levels of Erlotinib (OSI-774)
- Plasma Calculated Concentration - OSI-420 (ng/mL) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]Plasma concentration levels of Erlotinib (OSI-420)
- Pancreas Calculated Concentration - OSI-420 (ng/g) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]Pancreatic tissue concentration levels of Erlotinib (OSI-420)
- Number of Participants Reported at Least 1 Adverse Event With a Grade of 3 and Above [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: Yes ]The worst grade of pre-listed toxicity will be summarized by participant and by visit for each treatment group. Descriptive statistics (frequencies and percents) will be used to summarize data and hypotheses about group differences will be tested where appropriate.
|Study Start Date:||June 2007|
|Study Completion Date:||September 2013|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
Drug: erlotinib hydrochloride
Other Names:Procedure: conventional surgery
Other Name: surgery, conventionalOther: immunohistochemistry staining method
Other Name: immunohistochemistryGenetic: protein expression analysis
Correlative studiesProcedure: biopsy
Other Name: biopsiesOther: pharmacological study
Other Name: pharmacological studiesOther: laboratory biomarker analysis
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 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482625
|United States, California|
|University of California Medical Center At Irvine-Orange Campus|
|Orange, California, United States, 92868|
|Principal Investigator:||Steven M Lipkin, MD,PhD||Weill Cornell College of Medicine|