Colorectal Cancer Clinical Trial
Official title:
A Phase II Study of Oral Xeloda in Combination With Intravenous Irinotecan for Patients With Locally Advanced and/or Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
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.
OBJECTIVES:
- Determine the overall objective response rate in patients with locally advanced,
locally recurrent, or metastatic colorectal cancer treated with capecitabine and
irinotecan.
- Determine the time to treatment failure, time to 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.
;
Primary Purpose: Treatment
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