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

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.

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 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 PT/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 CHF greater than 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 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.