Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, 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.
Drug: irinotecan hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Oral Xeloda in Combination With Intravenous Irinotecan for Patients With Locally Advanced and/or Metastatic Colorectal Cancer|
|Study Start Date:||March 2001|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022698
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|United States, California|
|Loma Linda University Cancer Institute at Loma Linda University Medical Center|
|Loma Linda, California, United States, 92354|
|United States, Connecticut|
|Eastern Connecticut Hematology and Oncology Associates|
|Norwich, Connecticut, United States, 06360|
|United States, District of Columbia|
|Lombardi Cancer Center at Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|George Washington University Medical Center|
|Washington, District of Columbia, United States, 20037|
|United States, Florida|
|University of Florida Health Science Center - Jacksonville|
|Jacksonville, Florida, United States, 32209|
|United States, Kentucky|
|Markey Cancer Center at University of Kentucky Chandler Medical Center|
|Lexington, Kentucky, United States, 40536-0084|
|United States, Missouri|
|St. Louis University Hospital Cancer Center|
|Saint Louis, Missouri, United States, 63110-0250|
|United States, New York|
|Lincoln Medical and Mental Health Center|
|Bronx, New York, United States, 10451|
|Brooklyn, New York, United States, 11235|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19107-5541|
|United States, South Carolina|
|Charleston Hematology-Oncology, P.A.|
|Charleston, South Carolina, United States, 29403|
|United States, Virginia|
|Cancer Center at the University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|United States, Washington|
|Swedish Cancer Institute at Swedish Medical Center - First Hill Campus|
|Seattle, Washington, United States, 98104|
|Rockwood Clinic P.S.|
|Spokane, Washington, United States, 99202|
|United States, West Virginia|
|West Virginia University Hospitals|
|Morgantown, West Virginia, United States, 26506-9300|
|Study Chair:||Mike Andria||Hoffmann-La Roche|