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Phase I/II Study of Chemoprevention With EGFR and COX-2 Inhibitor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00314262
Recruitment Status : Completed
First Posted : April 13, 2006
Results First Posted : October 24, 2014
Last Update Posted : October 24, 2014
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Dong Shin, Emory University

Study Description
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Brief Summary:
Evaluate effect on cells and patient response to study medications, assess side effects of these medications, and evaluate chemicals in cells that may tell how the drug works, before, and after receiving the study medications.

Condition or disease Intervention/treatment Phase
Precancerous Conditions Drug: Erlotinib & Celecoxib Phase 1 Phase 2

Detailed Description:

The purpose of this study is to evaluate the effect on cells and patient response to study medications, assess the side effects of these medications, and to evaluate chemicals in the cells that may tell how the drug works, before, and after receiving the study medications.

Approximately 61 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital in Atlanta, Georgia.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase I/II Study of Chemoprevention With Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva) and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib) in Premalignant Lesions of Head and Neck of Former Smokers
Study Start Date : October 2006
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Erlotinib & Celecoxib Drug: Erlotinib & Celecoxib

Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.

Celecoxib given 400 mg orally BID continuously for 6 months.

Other Name: OSI-774, Tarceva


Outcome Measures
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Primary Outcome Measures :
  1. Dose Escalation and Toxicity: Toxicities Including Grades 1 to 4 [ Time Frame: 12 months from time of enrollment ]
    Participants received a fixed dose of celecoxib 400 mg orally BID continuously for 6 months. Erlotinib was dose escalated at 3 dose levels of 50, 75, and 100 mg orally every day for 6 months. Dose escalation followed a standard 3+3 escalation design.

  2. Clinical Outcome: Documented Progression [ Time Frame: 12 months from time of enrollment ]
    Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist. Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium. Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia). Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment. Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.

  3. Clinical Outcome: Progression to a Higher-grade Dysplasia or Carcinoma [ Time Frame: Up to 55 months from initiation of therapy. Median duration of follow-up was 36 months. ]
    Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist. Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium. Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia). Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment. Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have premalignant lesions.
  • Lesion sites include oral cavity, oropharynx, and larynx.
  • Must have at least a >20 pack-year history of smoking.
  • Must have a Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-1.
  • Participants must be 18 years of age or older.
  • No contraindications for laryngoscopy and biopsy.
  • Adequate liver function.
  • Must have hemoglobin and hematocrit levels at or above the lower limit of the normal range.
  • Participants must have prothrombin time (PT)/partial thromboplastin time (PTT) levels at or above the lower limit of the normal range.
  • Women of child-bearing potential must have a negative serum pregnancy test within 72 hours of receiving treatment.
  • Must be able to swallow the oral dose of erlotinib and celecoxib.
  • Participants must be disease free.
  • Final eligibility will be determined by the health professionals conducting the trial.

Exclusion Criteria:

  • Participants with acute intercurrent illness or those who had surgery within the preceding 4 weeks unless they have fully recovered.
  • History of previous malignancies unless the cancer was stage I or II and rendered free of disease more than 1 year.
  • Pregnant or breast feeding.
  • Not practicing adequate contraception if the participants are of child bearing potential.
  • Female patients who have a positive pregnancy test.
  • History or recent myocardial infarction.
  • Hypertension not adequately controlled by medication.
  • Documented history of coagulopathy.
  • Documented history of congestive heart failure (CHF) greater than New York Heart Association (NYHA) Grade II.
  • Participants who were taking COX-2 inhibitors or EGFR tyrosine kinase inhibitors within 3 months of study entry.
  • Documented history or interstitial lung disease.
  • Known connective tissue disease.
  • History of nonsteroidal antiinflammatory drug (NSAID)-induced ulcers or those who are at risk for a GI ulcer.
  • Participated in a clinical trial of an investigational drug within 12 months prior to enrollment.
  • Final eligibility will be determined by the health professionals conducting the trial.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314262


Locations
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United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Dong Shin, MD Emory University Winship Cancer Institute
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Dong Shin, MD, Emory University
ClinicalTrials.gov Identifier: NCT00314262    
Other Study ID Numbers: IRB00024922
First Posted: April 13, 2006    Key Record Dates
Results First Posted: October 24, 2014
Last Update Posted: October 24, 2014
Last Verified: October 2014
Keywords provided by Dong Shin, Emory University:
Skin Lesions
Premalignant Lesion
Additional relevant MeSH terms:
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Precancerous Conditions
Neoplasms
Celecoxib
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors