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