Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer

Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not curable with conventional therapy Recurrent or metastatic disease At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques At least 10 mm by spiral CT scan Target lesion must not be in a previously irradiated field unless progression of this lesion has been documented No known brain metastases Performance status - ECOG 0-2 Performance status - Karnofsky 60-100% More than 3 months WBC at least 1,500/mm^3 Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST or ALT no greater than 3 times ULN (5 times ULN if liver metastases present) Creatinine no greater than 1.25 times ULN Creatinine clearance at least 50 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation No active peptic ulcer disease No unresolved complete or subacute bowel obstruction No severe enteropathy that would interfere with absorption of study drug No abnormalities of the cornea: Dry eye syndrome or Sjogren's syndrome Congenital abnormality (e.g., Fuch's dystrophy) Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) Abnormal corneal sensitivity test (Schirmer test or similar tear production test) No significant traumatic injury within the past 21 days No ongoing or active infection No psychiatric illness or social situation that would preclude study No other concurrent uncontrolled illness that would preclude study No other malignancy within the past 3 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No more than 1 prior chemotherapy regimen for metastatic disease with either fluorouracil (5-FU) and oxaliplatin or 5-FU and a topoisomerase inhibitor (e.g., irinotecan), OR 5-FU (or other single-agent fluoropyrimidine, such as capecitabine) followed by irinotecan for advanced disease Prior adjuvant chemotherapy allowed At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered At least 3 weeks since prior major surgery No prior surgical procedures affecting absorption No prior epidermal growth factor receptor-targeting therapy No other concurrent investigational therapies No other concurrent anticancer therapy No concurrent combination anti-retroviral therapy for HIV-positive patients No concurrent warfarin Low molecular weight heparin allowed