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.