Erlotinib Prevention of Oral Cancer (EPOC)

Inclusion Criteria:

1. Male or female patients with one of the following: (a) loss of heterozygosity (LOH) at 3p14 and/or 9p21 in the oral Intraepithelial neoplasia (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.
2. 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).
3. Age >/= 18 years
4. Eastern Cooperative Oncology Group (ECOG) performance status <2
5. Participants must have normal organ & marrow function as defined below within 30 days of randomization: complete blood count (CBC) with differential white cell count (WBC)-acceptable results must include: WBC >3,000ul, hemoglobin>10 g/dl, platelet count > 125,000ul, Liver Function Tests (LFTs)-total bilirubin & alkaline phosphatase, aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) all within <1.5*upper limits of normal (ULN). Note:At the discretion of the attending physician,participants with Gilbert's disease may still be eligible to participate in the event the total bilirubin value is >1.5*ULN. Kidney function-serum creatinine< 1.5*ULN Chemistry-Sodium & potassium all within normal institutional limits.
6. The effects of the study agent on the developing human fetus are unknown. For this reason, Women of Childbearing Potential (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. Negative serum pregnancy test in WOCBP. Childbearing potential will be defined as women who have had menses within the past 12 months, 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
7. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

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