Erlotinib Hydrochloride in Treating Patients With Previously Treated Non-Small Cell Lung Cancer, Head and Neck Cancer, or Esophageal Cancer and Precancerous Lesions of the Lung

Erlotinib Hydrochloride in Treating Patients With Previously Treated Non-Small Cell Lung Cancer, Head and Neck Cancer, or Esophageal Cancer and Precancerous Lesions of the Lung
This study is currently recruiting participants.
Verified March 2011 by Northwestern University

First Received on November 13, 2009.  
Last Updated on March 9, 2011  
History of Changes
Sponsor: Northwestern University
Collaborator: National Cancer Institute (NCI)
Information provided by: Northwestern University
ClinicalTrials.gov Identifier: NCT01013831
  Purpose

RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib hydrochloride in treating patients with previously treated non-small cell lung cancer, head and neck cancer, or esophageal cancer with precancerous lesions of the lung.

Condition Intervention Phase
Cancer Survivor
Esophageal Cancer
Head and Neck Cancer
Lung Cancer
Precancerous Condition
Drug: Erlotinib Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I Study of Erlotinib in Patients With Premalignant Lesions of the Lung

Resource links provided by NLM:

Further study details as provided by Northwestern University:

Primary Outcome Measures:

  • Decrease in the ratio of phosphorylated to total EGFR [ Time Frame: Measured at treatment completion (3 months) ] [ Designated as safety issue: No ]
    The decrease in the ratio of phosphorylated to total EGFR will be measured at treatment completion by immunohistochemistry on pre-treatment and post-treatment biopsy specimens.

Secondary Outcome Measures:

  • Effect of erlotinib on disease biomarkers [ Time Frame: Measured at treatment completion (3 months) ] [ Designated as safety issue: No ]
    The effect of erlotinib on disease biomarkers will be measured by comparing pre-treatment and post treatment results.

  • Characterize the toxicities for erlotinib in this population [ Time Frame: Measured day 1, monthly during treatment and 1 month post treatment ] [ Designated as safety issue: Yes ]
    Adverse events will be collected on day 1, monthly during treatment and 1 month post treatment.

  • Pharmacokinetics and pharmacodynamics of erlotinib hydrochloride [ Time Frame: Day 1 and day 30 of treatment ] [ Designated as safety issue: No ]
    Serial blood draws for pharmacokinetics and pharmacodynamics of erlotinib hydrochloride taken day 1 and day 30 of treatment

Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions
Experimental: Erlotinib

De-escalating doses of erlotinib beginning at 75mg
Drug: Erlotinib

De-escalating doses starting with 75mg orally taken once per day for 90 days
Other Names:
  • erlotinib hydrochloride
  • tarceva

Detailed Description:

OBJECTIVES:

Primary

  • To determine the toxicity and safety of multiple low doses of erlotinib hydrochloride in patients with a history of previously treated aerodigestive cancer and a recently diagnosed premalignant lesion of the lung.

Secondary

  • To determine the efficacy of each dose level of erlotinib hydrochloride on the modulation of molecular markers in lung biopsies.
  • To determine the significance of the change in expression of primary biomarkers (total epidermal growth factor receptor [EGFR] and phosphorylated-EGFR [p-EGFR]) between pre- and post-treatment lung biopsies.
  • To determine the significance of the change in expression of secondary biomarkers (p-Akt, p-Erk, Ki67, and Bcl2).

Tertiary

  • To model the responses to treatment by evaluating the pharmacokinetics/pharmacodynamics of erlotinib hydrochloride, the polymorphisms in the EGFR gene and in genes responsible for erlotinib hydrochloride metabolism and transport, and the optimal biologic concentration of erlotinib hydrochloride.

OUTLINE: Patients are stratified according to smoking status (current vs former/never smokers).

Patients receive oral erlotinib hydrochloride once daily for 90 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection periodically for correlative biomarker, pharmacokinetic, and pharmacogenetic studies.

After completion of study treatment, patients are followed up at 30 days.

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of aerodigestive cancer (non-small cell lung cancer, head and neck cancer, or esophageal cancer)

    • Completed treatment (surgery, chemotherapy, and/or radiotherapy) ≥ 1 year ago
    • No evidence of active or current disease, including carcinoma in situ, as confirmed by a clinical visit and spiral CT scan within the past 30 days
  • Diagnosis of a premalignant lung lesion (metaplasia or dysplasia) on autofluorescence bronchoscopy (AFB) within the past month

    • If bronchoscopy was performed > 1 month before evaluation, patient will be considered for study enrollment after their next AFB

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • ANC ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Creatinine < 1.5 mg/dL
  • Total bilirubin ≤ 2.0 mg/dL
  • Alkaline phosphatase ≤ 2.5 times upper limit of normal
  • Albumin of ≥ 2.5 g/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No contraindications for treatment with erlotinib hydrochloride or additional bronchoscopies
  • No life-threatening medical condition that would preclude bronchoscopy, including acute cardiac failure that is unstable despite medication use, uncontrolled hypertension, uncontrolled diabetes mellitus, or unstable coronary artery disease
  • No history of interstitial lung disease
  • No history of allergic reactions attributed to erlotinib hydrochloride or a known hypersensitivity to erlotinib hydrochloride
  • No uncontrolled or ongoing illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent medications that induce or inhibit the CYP3A4-7 enzymes
  • No other concurrent investigational agents
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013831

Contacts
Contact: Raymond Bergan, MD 312-908-5284 r-bergan@northwestern.edu
Contact: study coordinator 312-695-1301 cancertrials@northwestern.edu

Locations
United States, Illinois
Northwestern University Active, not recruiting
Chicago, Illinois, United States, 60611-3013
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Mary Reid, PhD     716-845-1209     mary.reid@roswellpark.org    
Contact: Alex Adjei, MD, PhD     716-845-4101     alex.adjei@roswellpark.org    
Principal Investigator: Alex Adjei, MD, PhD            
Sub-Investigator: Martin Mahoney, MD, PhD            
Sub-Investigator: Samjot Dhillon, MD            
Sub-Investigator: Saikrishna Yendamuri, MD            
Sub-Investigator: Richard Cheney, MD            
Principal Investigator: Paul Bogner, MD            
Sub-Investigator: Lakshmi Pendyala, PhD            
Sub-Investigator: Gerald Fetterly, PhD            
Sub-Investigator: Araba Adjei, PhD            
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Raymond C. Bergan, MD Northwestern University
Principal Investigator: Alex A. Adjei, MD, PhD Roswell Park Cancer Institute
Study Chair: Mary Reid, PhD Roswell Park Cancer Institute
  More Information

Additional Information:

No publications provided

Responsible Party: Dr. Raymond Bergan, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT01013831    
History of Changes
Other Study ID Numbers: NCI 08-11-01, P30CA060553, NU-NWU08-11-01, NCI-08-11-01, RPCI-I-121507, STU00012618
Study First Received: November 13, 2009
Last Updated: March 9, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Northwestern University:

cancer survivor
high-grade salivary gland mucoepidermoid carcinoma
low-grade salivary gland mucoepidermoid carcinoma
occult non-small cell lung cancer
salivary gland acinic cell tumor
salivary gland adenocarcinoma
stage 0 non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
stage II squamous cell carcinoma of the larynx
stage II verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
stage I adenoid cystic carcinoma of the oral cavity
stage I mucoepidermoid carcinoma of the oral cavity
stage I verrucous carcinoma of the oral cavity
stage II adenoid cystic carcinoma of the oral cavity
stage II mucoepidermoid carcinoma of the oral cavity
stage II verrucous carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage III verrucous carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV verrucous carcinoma of the oral cavity

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Esophageal Diseases
Esophageal Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Precancerous Conditions
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2012

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