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Orzel (UFT+Leucovorin) as First-Line Therapy for Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Orzel (UFT+Leucovorin) as First-Line Therapy for 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

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

William J. Gradishar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:

NU 99B3



Start Date:

February 2000

Completion Date:

June 2002

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms



Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611