A Phase II Study of Oral Xeloda in Combination With Intravenous Irinotecan for Patients With Locally Advanced and/or Metastatic Colorectal Cancer
- Determine the overall objective response rate in patients with locally advanced,
locally recurrent, or metastatic colorectal cancer treated with capecitabine and
- 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
- 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
United States: Federal Government
|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|