OBJECTIVES:~Primary:~Determine the overall objective response rate in patients with locally advanced, locally recurrent, or metastatic colorectal cancer treated with capecitabine and irinotecan.~Secondary:~Determine the time to treatment failure, time to overall response, duration of overall response, duration of overall complete response, and time to progression in patients treated with this regimen.~Determine the 1-year survival and overall survival of patients treated with this regimen.~Determine the toxicity and safety profile of this regimen in these patients.~Determine the feasibility of predicting responses to this regimen by the molecular profile of tumor tissue in patients treated with this regimen.~OUTLINE: This is a multicenter study.~Patients receive oral capecitabine twice daily on days 2-15 and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients maintaining a response or stable disease after 12 courses may continue treatment at the discretion of the investigator.~Patients are followed every 3 months.~PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 9 months.
PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.