Protocol for Assessment of Capecitabine for Advanced Colorectal Cancer in Patients Aged 70 Years and Older (and in a Cohort of Patients Younger than 60 Years)

Histologically or cytologically confirmed diagnosis of metastatic or recurrent colorectal cancer that is not resectable. Must be 70 years or older, or less than 60 years. Patient must be willing to submit specimens for research purposes. Must have measurable disease. Adequate renal function and bone marrow reserve. No prior chemotherapy for advanced disease. Prior adjuvant chemotherapy allowed if recurrence was more than 12 months after the last adjuvant treatment. No known brain metastases or seizure disorder. Prestudy MRI or CT scan required. Zubrod performance status 0-2. No pregnant or nursing women. No HIV positive patients. No other prior malignancy allowed except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.