7 Day's of Erlotinib Neo-adjuvant, Followed by Adjuvant Erlotinib-gemcitabine in Pancreatic Cancer Patients
Status:
Terminated
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
1.1 Primary Objective
To evaluate the effects of short course preoperative erlotinib treatment in a panel of
predictive biomarkers from a group of patients who undergo resection of pancreatic
adenocarcinoma with curative intent.
1.2 Secondary Objectives
1.2.1 To analyze the effects of short course preoperative erlotinib treatment followed by
postoperative erlotinib-gemcitabine therapy in the disease-free survival of patients who
undergo curative intent resection of pancreatic adenocarcinoma.
1.2.2 To evaluate secondary endpoints of disease response such as duration of overall
survival and patterns of recurrence for patients with resectable pancreatic cancer who
undergo this treatment regimen.
1.2.3 To evaluate the plasma pharmacokinetics of erlotinib in pancreatic cancer patients both
in the preoperative and postoperative setting, and to explore correlations between plasma and
tumor erlotinib concentrations.
1.2.4 To develop a clinically relevant predictive assay of response to erlotinib based on
selected biomarkers in endoscopic ultrasound-fine needle aspiration (EUS-FNA) specimens when
it can be obtained at the time of pancreatic cancer diagnosis in chemotherapy-naive patients.