Phase IIA Trial Testing Erlotinib as an Intervention Against Intraductal Pancreatic Mucinous Neoplasms

Inclusion Criteria:

- Confirmed IPMN histological diagnosis, endoscopic ultrasound fine needle aspiration
(EUS-FNA) core biopsy tissue specimen with plan for pancreatic surgical resection;
histological diagnosis should be within 6 months of entry into protocol

- Patients must have adequate bone marrow function at study entry

- White blood cell (WBC) > 3,000

- Platelets > 100,000/mm^3

- Hemoglobin > 10 g/dL

- Plasma creatinine of < 1.6 mg/dL

- Total bilirubin < 1.5

- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.5 x
upper limit of normal

- Patients with evidence of obstructive lung disease (forced expiratory volume in one
second [FEV1] < 80% predicted and FEV1/forced vital capacity [FVC] ratio < 90% of
predicted value) as the etiology of a low diffusing capacity will still be eligible
as long as the chest radiograph or computed tomography (CT) does not demonstrate
interstitial changes

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Women of child-bearing potential and men taking study drug must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to
study entry and for the duration of study participation

- Ability to understand, as well as sign the written informed consent document

- If a woman of child-bearing potential, must have a negative pregnancy test prior to
study entry; should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her study physician immediately

Exclusion Criteria:

- Intake of EGFR antagonist, Erbitux (cetuximab)

- Previous history of sensitivity to Tarceva (erlotinib hydrochloride), Iressa
(gefitinib), or Erbitux, such as a rash that is uncontrollable by topical steroids
and/or antibiotics

- Uncontrollable diarrhea of any cause

- Active keratoconjunctivitis, or corneal surgery in the past three weeks

- Participants taking a known cytochrome P450 3A4 (CYP 3A4) inducer (e.g., phenytoin,
carbamazepine, St. John's wort, and rifampin) and medications known to be inhibitors
or metabolized by CYP3A4; these inhibitors include erythromycin, clarithromycin and
ketoconazole, and patients taking them will be excluded since these drugs may be
expected to result in altered exposure of Erlotinib

- Hospitalization within the past 5 years for mania or for bipolar disease

- Participants may not be receiving any other investigational pharmaceutical agents

- Women who are breast-feeding should not receive Erlotinib

- Any medical or psychosocial condition that, in the opinion of the investigator, could
jeopardize the subject's participation in and compliance to the study