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

Phase 2
18 Years
Not Enrolling
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

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Trial Information

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


I. To test the hypothesis that the activated epidermal growth factor receptor (EGFR) signal
transduction biomarker Mucin 5AC (MUC5AC) protein expression within intraductal pancreatic
mucinous neoplasm (IPMN) lesions will have greater than zero absolute mean decrease from
baseline comparing pre and post 21-42 days of Erlotinib (erlotinib hydrochloride)
administration at 100mg orally (PO) once daily (QD).


I. To test the hypothesis that other correlative IPMN EGF inducible biomarkers will have
greater than zero absolute mean decrease from baseline pre and post Erlotinib 100mg PO QD

II. Safety of Erlotinib treatment. III. To determine Erlotinib pharmacokinetic concentration
in plasma and pancreatic tissue at the 100mg/day dose up to 42 days of therapy.


Patients receive erlotinib hydrochloride PO QD for 21-42 days in the absence of disease
progression or unacceptable toxicity. Patients then undergo to pancreatectomy.

After completion of study treatment, patients are followed up at 4-20 weeks.

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Greater than zero absolute mean decrease in MUC5AC expression

Outcome Description:

This measurement is a continuous variable. A single group univariate repeated measures analysis of variance will be used to detect differences over time in biomarker expression. Changes over time will be tested using univariate analysis of variance for repeated measures.

Outcome Time Frame:


Safety Issue:


Principal Investigator

John Lee

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chao Family Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

December 2012

Related Keywords:

  • 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
  • Neoplasms
  • Pancreatic Neoplasms



University of California Medical Center At Irvine-Orange Campus Orange, California  92868