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

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.