Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma

Inclusion Criteria:

Participants with one or more of the following criteria will be eligible to participate:

History of Stage I-III colorectal cancer, not treated in the past 6 months with no anticipated treatment in the next 3 months
Adenoma ≥ 1 cm in size
3 or more adenomas (of any size) removed at one colonoscopy within past 6 years
Sessile serrated adenoma ≥ 5 mm in size
Adenoma (of any size) with villous features (villous, tubulovillous)
Adenoma (of any size) with high grade dysplasia
Participants are eligible for randomization into the treatment phase of the trial if they are found to have ≥ 4 ACFs at either baseline colonoscopy or baseline flexible sigmoidoscopy
Blood tests at screening which meet the following criteria:
WBC > 3000/mm^3
Platelets > 100,000/mm^3
Hemoglobin > 10g/dl
Plasma creatinine of < 1.6mg/dl
Total bilirubin < 1.5 x the upper limit of normal
Serum ALT < 1.5 x the upper limit of normal
Serum AST < 1.5 x the upper limit of normal
ECOG performance status 0-1
Women of child-bearing potential and men taking study drug must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Ability to understand, as well as sign the written informed consent document
If a woman is of child-bearing potential, she must have a negative pregnancy test prior to study entry; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately

Exclusion Criteria:

History of Inflammatory Bowel Disease (IBD)
History of interstitial lung disease or chronic lung disease
Smoking within the past 3 months
Increased bleeding risk from rectal biopsy (Patients receiving aspirin or plavix can be enrolled)
Patients receiving warfarin or coumadin
Uncontrollable diarrhea of any cause
Patients, including rectal cancer patients, that have received prior radiation to the rectum or pelvis
Participants taking a known significant CYP 3A4 inducer or inhibitor; known significant inducers/inhibitors include: amprenavir, aprepitant, atazanavir, carbamazepine, clarithromycin, conivaptan, diltiazem, darunavir/ritonavir, dronedarone, erythromycin, fluconazole, fosamprenavir, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, phenytoin, posaconazole, rifampin, ritonavir, St. John's wort, saquinavir, telithromycin, tipranavir/ritonavir, verapamil, voriconazole
Women who are pregnant or breast-feeding
Active keratoconjunctivitis, or corneal surgery in the past three weeks
Any medical or psychosocial condition that could jeopardize the subject's participation in and compliance to the study
Participants who are taking any other investigational pharmaceutical agents
Previous history of sensitivity to erlotinib, Iressa, or Erbitux, such as a rash that is uncontrollable by topical steroids and/or antibiotics