Erlotinib Prevention of Oral Cancer (EPOC)

Inclusion Criteria

• Male or female patients with one of the following: (a) loss of heterozygosity (LOH) at 3p14 and/or 9p21 in the oral IEN of patients with a history of curatively treated oral cancer or (b) LOH at 3p14 and/or 9p21 plus at one other chromosomal region in the IEN of patients with no oral cancer history.
• Participants must have confirmed diagnosis of oral IEN lesion with LOH. (Note:The initial screening biopsy of oral IEN lesion with LOH must be obtained within 12 months of study enrollment. If initial diagnostic biopsy for LOH is > 3 months prior to study enrollment, investigators may use clinical judgment to order an additional screening biopsy to assess histopathological changes).
• Age >/= 18 years
• ECOG performance status 3, 000ul, hemoglobin>10 g/dl, platelet count > 125,000ul, LFTs-total bilirubin & alkaline phosphatase, AST (SGOT) & ALT (SPGT) all w/in 1.5xULN. Kidney function-serum creatinine< 1.5xULN Chemistry-Sodium & potassium all w/in normal institutional limits.
• The effects of the study agent on the developing human fetus are unknown.For this reason,WOCBP & men must agree to use adequate contraception (hormonal or barrier method of birth control;abstinence)prior to study entry& for the duration of active treatment.Neg.serum pregnancy test in WOCBP.Childbearing potential will be defined as women who have had menses w/in the past 12 mths,who have not had tubal ligation or bilateral oophorectomy.Should a woman become pregnant or suspect she is pregnant while participating in this study,she should inform her study physician immediately
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Patients with active cancer or any cancer within the previous two years, excluding oral and non-melanoma skin cancer.
• Patients with acute intercurrent illness or who have had surgery, radiation therapy, or chemotherapy within the preceding 4 weeks unless they have fully recovered.
• Patients with a documented history of coagulopathy and/or those taking warfarin or warfarin-derivative anticoagulants
• Women who are pregnant (confirmed by b-HCG if applicable) or breastfeeding
• Any medical or psychological condition or any reason that, according to the investigator's judgment, makes the patient unsuitable for participation in the study
• Patients who have participated in other experimental therapy studies within 3 months of enrollment to this trial
• Patients with a history of inflammatory bowel disease
• Patients with a documented history of interstitial lung disease