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 \<2
• . Participants must have normal organ \& marrow function as defined below w/in 30 days of randomization:CBC w/ differential white cell count-acceptable results must include:WBC \>3,000ul, hemoglobin\>10 g/dl, platelet count \> 125,000ul, LFTs-total bilirubin \& alkaline phosphatase, AST (SGOT) \& ALT (SPGT) all w/in \<1.5xULN.Note:At the discretion of the attending physician,participants w/ Gilbert's disease may still be eligible to participate in the event the total bilirubin value is \>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