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

The purpose of this study is to determine the efficacy of an oral investigational drug in patients with refractory metastatic colorectal cancer after receiving prior therapy with 5-fluorouracil in combination with irinotecan 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.