Breast Cancer Clinical Trial
Official title:
Orzel (UFT+Leucovorin) as First-Line Therapy for 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.
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.
;
Primary Purpose: Treatment
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