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

Inclusion Criteria

• •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