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

NCT ID: NCT00482625

Last Updated: 2014-10-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2013-09-30

Brief 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

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (enzyme inhibitor therapy)

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

Group Type: EXPERIMENTAL

erlotinib hydrochloride

Intervention Type: DRUG

Given PO

conventional surgery

Intervention Type: PROCEDURE

Undergo pancreatectomy

immunohistochemistry staining method

Intervention Type: OTHER

Correlative studies

protein expression analysis

Intervention Type: GENETIC

Correlative studies

biopsy

Intervention Type: PROCEDURE

Correlative studies

pharmacological study

Intervention Type: OTHER

Correlative studies

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

erlotinib hydrochloride

Given PO

Intervention Type: DRUG

conventional surgery

Undergo pancreatectomy

Intervention Type: PROCEDURE

immunohistochemistry staining method

Correlative studies

Intervention Type: OTHER

protein expression analysis

Correlative studies

Intervention Type: GENETIC

biopsy

Correlative studies

Intervention Type: PROCEDURE

pharmacological study

Correlative studies

Intervention Type: OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

CP-358,774; erlotinib; OSI-774; surgery, conventional; immunohistochemistry; biopsies; pharmacological studies

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven M Lipkin, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell College of Medicine

Locations

University of California Medical Center At Irvine-Orange Campus

Orange, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 14520092 (View on PubMed)

Other Identifiers

UCI 06-30

Identifier Type: -

Identifier Source: secondary_id

N01CN35160

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000547235

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2009-00898

Identifier Type: -

Identifier Source: org_study_id