GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin

Inclusion Criteria: * Provide signed informed consent. * Refractory Stage IV metastatic colorectal cancer. * Received at least 2 cycles of first-line therapy with intravenous 5-FU (5-fluorouracil) in combination with CPT-11 (irinotecan) and/or oxaliplatin. * No more than one prior therapy. * Tumor tissue available for testing. * 4 weeks since first-line cancer regimen. * Able to swallow and retain oral medication. * Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan). * Adequate kidney and liver function. * Adequate bone marrow function. Exclusion Criteria: * Pregnant or lactating female. * Conditions that would affect absorption of an oral drug * First-line regimen did not include 5-fluorouracil with irinotecan and/or oxaliplatin. * Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent. * Severe cardiovascular disease or cardiac (heart) disease requiring a device. * Active infection. * Brain metastases. * Concurrent cancer therapy or investigational therapy. * Use of oral or intravenous steroids. * Unresolved or unstable, serious toxicity from prior therapy. * Prior therapy with an EGFR (Endothelial Growth Factor Receptor) and/or erbB-2 inhibitor.