Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast 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 fluorouracil-uracil and leucovorin in treating women who have metastatic breast cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Orzel (UFT+Leucovorin) as First-Line Therapy for Metastatic Breast Cancer|
|Study Start Date:||February 2000|
|Study Completion Date:||June 2002|
|Primary Completion Date:||June 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the objective response rate in women with metastatic breast cancer treated with fluorouracil-uracil and leucovorin calcium as first line therapy. II. Determine time to disease progression in this patient population treated with this regimen. III. Evaluate the toxicity profile of this regimen in these patients.
OUTLINE: Patients receive oral fluorouracil-uracil and oral leucovorin calcium twice daily for 28 days followed by 1 week of rest. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. Patients with responding disease receive a minimum of 6 courses of treatment. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 22-33 patients will be accrued for this study within 13-14 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005608
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611|
|Study Chair:||William J. Gradishar, MD||Robert H. Lurie Cancer Center|