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