Vanderbilt-Ingram Cancer Center

This is a single-arm, non-randomized phase II study. Eligible, fully registered patients will receive preoperative gemcitabine plus erlotinib, then exploratory laparotomy/pancreaticoduodenectomy, then postoperative gemcitabine plus erlotinib. After therapy, patients are followed for relapse and survival for four years.

Criteria
 DISEASE CHARACTERISTICS:

 • Histologically or cytologically confirmed adenocarcinoma of the pancreatic head or uncinate process

 • No tumors of the pancreatic neck, body, or tail

 • No evidence of neuroendocrine tumors, duodenal adenocarcinoma, or ampullary adenocarcinoma

 • Localized, potentially resectable* tumor by chest x-ray or CT scan and abdominal CT scan or MRI, as defined by the following:

 • No evidence of tumor extension to the celiac axis, hepatic artery, or superior mesenteric artery

 • No evidence of tumor encasement or occlusion of the superior mesenteric vein (SMV) or the SMV/portal vein confluence

 • No evidence of visceral or peritoneal metastases NOTE: *Patients with borderline resectable or marginally resectable pancreatic cancer are not eligible.

 PATIENT CHARACTERISTICS:

 • ECOG or Zubrod performance status 0-1

 • WBC ≥ 2,000/mm³

 • ANC ≥ 1,500/mm³

 • Platelet count ≥ 100,000/mm³

 • Total bilirubin ≤ 2.5 mg/dL

 • ALT and AST ≤ 2.5 times upper limit of normal

 • Albumin ≥ 3.2 g/dL

 • Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min

 • Baseline weight loss ≤ 15% of premorbid weight

 • No active infection requiring intravenous antibiotics

 • No other malignancy within the past 5 years except for nonmelanoma skin cancer or in situ cancer

 • Not pregnant or nursing

 • Negative pregnancy test

 • Fertile patients must use effective contraception

 PRIOR CONCURRENT THERAPY:

 • No prior EGFR-targeted therapy

 • No prior therapy for pancreatic cancer

 • No other concurrent investigational or commercial agents or therapies for pancreatic cancer