Erlotinib Hydrochloride In Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery

Study Overview

Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

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

PRIMARY OBJECTIVES: 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). SECONDARY OBJECTIVES: 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 therapy. 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. OUTLINE: 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.

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

DRUG: erlotinib hydrochloride
PROCEDURE: conventional surgery
OTHER: immunohistochemistry staining method
GENETIC: protein expression analysis
PROCEDURE: biopsy
OTHER: pharmacological study
OTHER: laboratory biomarker analysis

NCI-2009-00898
UCI 06-30
N01CN35160 (U.S. NIH Grant/Contract)
CDR0000547235 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-06-04	Results First Submitted 2014-04-18	Last Update Submitted that met QC Criteria 2014-10-07
First Submitted that Met QC Criteria 2007-06-04	Results First Submitted that Met QC Criteria 2014-04-18	Last Update Posted (ESTIMATED) 2014-10-16
First Posted (ESTIMATED) 2007-06-05	Results First Posted 2014-05-19	Last Verified 2014-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment (enzyme inhibitor therapy) Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.	DRUG: erlotinib hydrochloride Given PO PROCEDURE: conventional surgery Undergo pancreatectomy OTHER: immunohistochemistry staining method Correlative studies GENETIC: protein expression analysis Correlative studies PROCEDURE: biopsy Correlative studies OTHER: pharmacological study Correlative studies OTHER: laboratory biomarker analysis Correlative studies

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment (enzyme inhibitor therapy)

Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.

DRUG: erlotinib hydrochloride

Given PO

PROCEDURE: conventional surgery

Undergo pancreatectomy

OTHER: immunohistochemistry staining method

Correlative studies

GENETIC: protein expression analysis

Correlative studies

PROCEDURE: biopsy

Correlative studies

OTHER: pharmacological study

Correlative studies

OTHER: laboratory biomarker analysis

Correlative studies

Primary Outcome Measures	Measure Description	Time Frame
Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment	Number of participants showed a reduction in number of positive IPMN cells and staining intensity after treatment	Pre-treatment and post-treatment

Secondary Outcome Measures	Measure Description	Time Frame
Plasma Calculated Concentration - OSI-774 (ng/mL)	Plasma concentration levels of Erlotinib (OSI-774)	20 weeks
Pancreas Calculated Concentration - OSI-774 (ng/g)	Pancreatic tissue concentration levels of Erlotinib (OSI-774)	20 weeks
Plasma Calculated Concentration - OSI-420 (ng/mL)	Plasma concentration levels of Erlotinib (OSI-420)	20 weeks
Pancreas Calculated Concentration - OSI-420 (ng/g)	Pancreatic tissue concentration levels of Erlotinib (OSI-420)	20 weeks
Number of Participants Reported at Least 1 Adverse Event With a Grade of 3 and Above	The worst grade of pre-listed toxicity will be summarized by participant and by visit for each treatment group. Descriptive statistics (frequencies and percents) will be used to summarize data and hypotheses about group differences will be tested where appropriate.	Up to 20 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Steven M Lipkin, MD,PhD, Weill Cornell College of Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Armstrong WB, Wan XS, Kennedy AR, Taylor TH, Meyskens FL Jr. Development of the Bowman-Birk inhibitor for oral cancer chemoprevention and analysis of Neu immunohistochemical staining intensity with Bowman-Birk inhibitor concentrate treatment. Laryngoscope. 2003 Oct;113(10):1687-702. doi: 10.1097/00005537-200310000-00007.

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