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

NCT00482625 | Terminated Phase 2 Results DMC

• 4 other identifiers: NCI-2009-00898UCI 06-30N01CN35160CDR0000547235
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Plasma Calculated Concentration - OSI-774 (ng/mL)

  20 weeks

• Pancreas Calculated Concentration - OSI-774 (ng/g)

  20 weeks

• Plasma Calculated Concentration - OSI-420 (ng/mL)

  20 weeks

• Pancreas Calculated Concentration - OSI-420 (ng/g)

  20 weeks

• Number of Participants Reported at Least 1 Adverse Event With a Grade of 3 and Above

  Up to 20 weeks

Study Arms (1)

Treatment (enzyme inhibitor therapy)

EXPERIMENTAL

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

Drug: erlotinib hydrochloride; Procedure: conventional surgery; Other: immunohistochemistry staining method; Genetic: protein expression analysis; Procedure: biopsy; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

erlotinib hydrochloride DRUG

Given PO

Also known as: CP-358,774, erlotinib, OSI-774

Treatment (enzyme inhibitor therapy)

conventional surgery PROCEDURE

Undergo pancreatectomy

Also known as: surgery, conventional

Treatment (enzyme inhibitor therapy)

immunohistochemistry staining method OTHER

Correlative studies

Also known as: immunohistochemistry

Treatment (enzyme inhibitor therapy)

protein expression analysis GENETIC

Correlative studies

Treatment (enzyme inhibitor therapy)

biopsy PROCEDURE

Correlative studies

Also known as: biopsies

Treatment (enzyme inhibitor therapy)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (enzyme inhibitor therapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (enzyme inhibitor therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of California Medical Center At Irvine-Orange Campus

Orange, California, 92868, United States

Location

Related Publications (1)

• 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.

  PMID: 14520092 RESULT

MeSH Terms

Conditions

Pancreatic Intraductal Neoplasms; Pancreatic Neoplasms

Interventions

Erlotinib Hydrochloride; Surgical Procedures, Operative; Congresses as Topic; Immunohistochemistry; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Organizations; Health Care Economics and Organizations; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical

Results Point of Contact

• Title: Dr. Steven Lipkin
• Organization: Weill Cornell College of Medicine

stl2012@med.cornell.edu

212-774-7160

Study Officials

• Steven M Lipkin, MD,PhD

  Weill Cornell College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: June 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: September 1, 2013
• Last Updated: October 16, 2014
• Results First Posted: May 19, 2014

Record last verified: 2014-03

Locations

US (1)