Cetuximab and Capecitabine in Treating Patients With Metastatic Colorectal Cancer That Failed Irinotecan Treatment

DISEASE CHARACTERISTICS:

• Diagnosis of metastatic colorectal cancer
• Measurable disease

• Disease progression during prior fluoropyrimidine-containing therapy comprising irinotecan with or without oxaliplatin

  • Received standard first- and second-line irinotecan and oxaliplatin-based therapy

    • Patients who completed 1 prior treatment for metastatic disease but refused standard second-line therapy are eligible
  • Patients who's disease progressed within 6 months of previous therapy are eligible
• EGFR negative patients allowed
• No untreated or uncontrolled brain metastasis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Absolute neutrophil count ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• ALT ≤ 5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 5 times ULN
• Serum creatinine ≤ 1.5 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No serious intercurrent infections or medical problems
• No active or uncontrolled infections

• No significant history of uncontrolled cardiac disease, including any of the following:

  • Uncontrolled hypertension
  • Unstable angina
  • Myocardial infarction within the past 6 months
  • Uncontrolled congestive heart failure
  • Cardiomyopathy with decreased ejection fraction
• No prior severe infusion reaction to a monoclonal antibody
• No known dihydropyrimidine dehydrogenase deficiency or evidence of past hypersensitivity to fluoropyrimidine

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No more than 2 prior treatments for metastatic colorectal cancer
• More than 2 weeks since prior therapy
• Prior radiotherapy allowed if < 30% of bone marrow involvement
• No other concurrent investigational agents
• No concurrent highly active antiretroviral therapy for HIV-positive patients
• No prior therapy that specifically and directly targets the EGFR pathway