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

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.