Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma
Condition: Adenomatous Polyp; Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage I Colon Cancer; Stage I Rectal Cancer; Stage IIA Colon Cancer; Stage IIA Rectal Cancer; Stage IIB Colon Cancer; Stage IIB Rectal Cancer; Stage IIC Colon Cancer; Stage IIC Rectal Cancer; Stage IIIA Colon Cancer; Stage IIIA Rectal Cancer; Stage IIIB Colon Cancer; Stage IIIB Rectal Cancer; Stage IIIC Colon Cancer; Stage IIIC Rectal Cancer
MeSH terms: Rectal Neoplasms; Colonic Neoplasms; Adenomatous Polyps; Recurrence
Intervention: erlotinib hydrochloride; placebo; laboratory biomarker analysis
Intervention description: Given PO; Given PO; Correlative studies
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial is studying how well erlotinib hydrochloride works in treating
      patients with stage I-III colorectal cancer or adenoma. Erlotinib hydrochloride may stop the
      growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking
      blood flow to the tumor. Erlotinib hydrochloride may also stop tumors from growing or coming
      back
    

Eligibility criteria:

        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