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

October 7, 2014 updated by: National Cancer Institute (NCI)

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Other: immunohistochemistry staining method
Correlative studies
Other Names:
  • immunohistochemistry
Procedure: biopsy
Correlative studies
Other Names:
  • biopsies
Drug: erlotinib hydrochloride
Given PO
Other Names:
  • OSI-774
  • erlotinib
  • CP-358,774
Genetic: protein expression analysis
Correlative studies
Procedure: conventional surgery
Undergo pancreatectomy
Other Names:
  • surgery, conventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment
Time Frame: Pre-treatment and post-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

Outcome Measure
Measure Description
Time Frame
Plasma Calculated Concentration - OSI-774 (ng/mL)
Time Frame: 20 weeks
Plasma concentration levels of Erlotinib (OSI-774)
20 weeks
Pancreas Calculated Concentration - OSI-774 (ng/g)
Time Frame: 20 weeks
Pancreatic tissue concentration levels of Erlotinib (OSI-774)
20 weeks
Plasma Calculated Concentration - OSI-420 (ng/mL)
Time Frame: 20 weeks
Plasma concentration levels of Erlotinib (OSI-420)
20 weeks
Pancreas Calculated Concentration - OSI-420 (ng/g)
Time Frame: 20 weeks
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
Time Frame: Up to 20 weeks
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

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Steven M Lipkin, MD,PhD, Weill Cornell College of Medicine

Publications and helpful links

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

General Publications

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 Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

June 4, 2007

First Submitted That Met QC Criteria

June 4, 2007

First Posted (Estimate)

June 5, 2007

Study Record Updates

Last Update Posted (Estimate)

October 16, 2014

Last Update Submitted That Met QC Criteria

October 7, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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