• Mucin 5AC protein expression measured by IHC [ Designated as safety issue: No ]
  

• Change in tissue markers (including phosphorylated EGFR and AKT) measured by IHC [ Designated as safety issue: No ]
  
• Safety [ Designated as safety issue: Yes ]
  
• Pharmacokinetics [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Determine the effect of neoadjuvant erlotinib hydrochloride on mucin 5AC protein expression in patients with resectable intraductal pancreatic mucinous neoplasm (IPMN).

Secondary

• Determine the effect of this drug on phosphorylated EGFR and phosphorylated AKT in these patients.
• Determine the safety of this drug in these patients.
• Determine the pharmacokinetic concentration of this drug in plasma and pancreatic tissue of these patients.

OUTLINE: Patients receive oral erlotinib hydrochloride daily for 5-42 days. Patients then proceed to surgery.

Biopsies and blood samples are taken at baseline and after completion of erlotinib hydrochloride. Samples are assessed by IHC for mucin 5AC protein expression, total and phosphorylated EGFR, total and phosphorylated AKT, phosphorylated MAPK, claudin-4, vimentin, E-cadherin, and HER-3. Pharmacological studies are also conducted.

After surgery, patients are followed at 4-8 weeks.

DISEASE CHARACTERISTICS:

• Histologically confirmed intraductal pancreatic mucinous neoplasm (IPMN)

  • Planned pancreatic surgical resection
  • Endoscopic ultrasonography/fine-needle aspiration core biopsy tissue specimen available

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• WBC > 3,000/mm³
• Platelet count > 100,000/mm³
• Hemoglobin > 10 g/dL
• Creatinine < 1.6 mg/dL
• Bilirubin < 1.5 mg/dL
• AST and ALT < 1.5 times upper limit of normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Evidence of obstructive lung disease (FEV_1 < 80% predicted and FEV_1/forced vital capacity ratio < 90% of predicted value) allowed provided the chest radiograph or CT scan does not demonstrate interstitial changes
• No prior sensitivity (e.g., rash that is uncontrollable by topical steroids and/or antibiotics) to erlotinib hydrochloride, gefitinib, or cetuximab
• No other medical or psychosocial condition that, in the opinion of the investigator, would preclude study compliance
• No uncontrolled diarrhea of any cause
• No active keratoconjunctivitis
• No hospitalization for mania or bipolar disease within the past 5 years

PRIOR CONCURRENT THERAPY:

• No corneal surgery within the past 3 weeks
• No other concurrent investigational pharmaceutical agents
• No other concurrent EGFR antagonists (e.g., cetuximab)

• No concurrent agents known to effect CYP3A4 or metabolized by CYP3A4 including, but not limited to, any of the following:

  • Phenytoin
  • Carbamazepine
  • Hypericum perforatum (St. John's wort)
  • Rifampin
  • Erythromycin
  • Clarithromycin
  • Ketoconazole