Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: leucovorin calcium (Drug); tegafur-uracil (Drug); chemotherapy (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Robert H. Lurie Cancer Center
Official(s) and/or principal investigator(s):
William J. Gradishar, MD, Study Chair, Affiliation: Robert H. Lurie Cancer Center
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.
Official title: Orzel (UFT+Leucovorin) as First-Line Therapy for Metastatic Breast Cancer
Study design: Treatment
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
Minimum age: 18 Years.
Maximum age: N/A.
DISEASE CHARACTERISTICS: Metastatic breast cancer Bidimensionally measurable or evaluable
disease No bone metastases as only site of measurable or evaluable disease that has been
receiving bisphosphonate therapy for less than 2 months No known evidence of brain
metastases, lymphangitis lung metastases, or carcinomatous meningitis Hormone receptor
status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified
Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: WBC at least
3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin no greater than 1. 5 mg/dL AST or ALT no greater than 2. 5 times upper limit of
normal (ULN) Renal: Creatinine no greater than 1. 5 times ULN Calcium no greater than 1. 3
times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception No history of other cancers except curatively treated carcinoma in
situ of the cervix or nonmelanomatous skin cancer No active serious infection or other
serious underlying medical condition that would preclude study therapy No dementia or
significantly altered mental status that would preclude study consent No known
hypersensitivity to fluorouracil-uracil or leucovorin calcium
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Concurrent colony
stimulating factors (e. g., filgrastim (G-CSF), sargramostim (GM-CSF)) allowed only during
time off treatment during each course Chemotherapy: No prior chemotherapy for metastatic
disease At least 6 months since prior adjuvant chemotherapy and recovered Prior adjuvant
fluorouracil allowed provided not infusional No prior fluorouracil-uracil with or without
leucovorin calcium, capecitabine, S-1, or ethynyl uracil No other concurrent chemotherapy
Endocrine therapy: Prior hormonal therapy for metastatic disease or in adjuvant setting
allowed Recovered from toxicity No concurrent hormonal anticancer therapy Radiotherapy:
Prior radiotherapy for metastatic disease or in adjuvant setting allowed At least 2 weeks
since prior radiotherapy and recovered No prior radiotherapy to greater than 30% of bone
marrow No concurrent radiotherapy except for palliation of painful bone metastases,
pathologic fractures of known lytic disease, or brain lesions that develop Surgery: Not
specified Other: No other concurrent investigational therapy No other concurrent anticancer
drugs No concurrent halogenated antiviral agents (e. g., lodenosine, fialuridine, L-FMAU,
emtricitabine, or sorivudine) No concurrent initiation of bisphosphonate therapy for
development of new bone lesions or progression of existing bone lesions
Locations and Contacts
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois 60611, United States
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: February 2000
Last updated: October 25, 2007