Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00005608|
Recruitment Status : Terminated (Drug was pulled from the market.)
First Posted : April 19, 2004
Last Update Posted : June 6, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: leucovorin calcium Drug: tegafur-uracil||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Orzel (UFT+Leucovorin) as First-Line Therapy for Metastatic Breast Cancer|
|Study Start Date :||February 2000|
|Actual Primary Completion Date :||June 2002|
|Actual Study Completion Date :||June 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|