Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-01-01 @ 1:10 AM
Study NCT ID:
NCT00005608
Status:
TERMINATED
Last Update Posted:
2012-06-06
First Post:
2000-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
Orzel (UFT+Leucovorin) as First-Line Therapy for Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug was pulled from the market.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
PURPOSE: Phase II trial to study the effectiveness of fluorouracil-uracil and leucovorin in treating women who have metastatic breast cancer.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: