A Phase II Study of Oral Xeloda in Combination With Intravenous Irinotecan for Patients With Locally Advanced and/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.
Interventional
Primary Purpose: Treatment
Mike Andria
Study Chair
Hoffmann-La Roche
United States: Federal Government
CDR0000068843
NCT00022698
March 2001
Name | Location |
---|---|
George Washington University Medical Center | Washington, District of Columbia 20037 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
West Virginia University Hospitals | Morgantown, West Virginia 26506-9300 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
St. Louis University Hospital Cancer Center | Saint Louis, Missouri 63110 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
Lombardi Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
Rockwood Clinic P.S. | Spokane, Washington 99202 |
University of Florida Health Science Center - Jacksonville | Jacksonville, Florida 32209 |
Eastern Connecticut Hematology and Oncology Associates | Norwich, Connecticut 06360 |
HemOnCare, P.C. | Brooklyn, New York 11235 |
Lincoln Medical and Mental Health Center | Bronx, New York 10451 |
Charleston Hematology-Oncology, P.A. | Charleston, South Carolina 29403 |