Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
|ClinicalTrials.gov Identifier: NCT00482625|
Recruitment Status : Terminated (The protocol has been completed prematurely (e.g., due to poor accrual, insufficient drug supply, IND closure).)
First Posted : June 5, 2007
Results First Posted : May 19, 2014
Last Update Posted : October 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|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 Procedure: biopsy Other: pharmacological study Other: laboratory biomarker analysis||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IIA Trial Testing Erlotinib as an Intervention Against Intraductal Pancreatic Mucinous Neoplasms|
|Study Start Date :||June 2007|
|Primary Completion Date :||February 2010|
|Study Completion Date :||September 2013|
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
- Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment [ Time Frame: Pre-treatment and post-treatment ]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 ]Plasma concentration levels of Erlotinib (OSI-774)
- Pancreas Calculated Concentration - OSI-774 (ng/g) [ Time Frame: 20 weeks ]Pancreatic tissue concentration levels of Erlotinib (OSI-774)
- Plasma Calculated Concentration - OSI-420 (ng/mL) [ Time Frame: 20 weeks ]Plasma concentration levels of Erlotinib (OSI-420)
- Pancreas Calculated Concentration - OSI-420 (ng/g) [ Time Frame: 20 weeks ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|