Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer

Inclusion Criteria

• •Histologically confirmed metastatic adenocarcinoma of the colon or rectum, with measurable disease. The primary histologic diagnosis is sufficient if there is clear evidence by imaging and/or markers of metastatic disease sites.
• •Patients must have failed CPT-11 and oxaliplatin based therapies.
• •Patients must have received at least two prior chemotherapy regimens for advanced disease (completed \> 4 weeks prior to enrollment).
• •Tumor must be accessible for biopsy or paraffin embedded tissue must be available for review.
• •SWOG performance status 0-2.
• •AGC \>1000, platelets \>100,000.
• •Total bilirubin \< 3 x upper limit of normal. Transaminase (AST and/or ALT) \< 2 x upper limit of normal or \< 5 x upper limit of normal in patients with liver metastasis.
• •Patients must have a measured or calculated creatinine clearance greater than 35 mL/min obtained within 28 days prior to registration.
• •Age greater than or equal to 18 years
• •Patients should have hemoglobin \> 9 g/dL; patients may be transfused to achieve this level of hemoglobin.
• •Except for cancer-related abnormalities, patients should not have unstable or pre-existing major medical conditions.