Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
Condition: 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
MeSH terms: Neoplasms; Pancreatic Neoplasms; Neoplasms, Cystic, Mucinous, and Serous; Pancreatic Intraductal Neoplasms
Intervention: erlotinib hydrochloride; conventional surgery; immunohistochemistry staining method; protein expression analysis; biopsy; pharmacological study; laboratory biomarker analysis
Intervention description: Given PO; Undergo pancreatectomy; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor
      smaller and reduce the amount of normal tissue that needs to be removed. This phase II trial
      is studying how well erlotinib hydrochloride works in treating patients with pancreatic
      cancer that can be removed by surgery
    

Eligibility criteria:

        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