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