Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer

This study has been terminated.
(Drug was pulled from the market.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00005608
First received: May 2, 2000
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Breast Cancer
Drug: leucovorin calcium
Drug: tegafur-uracil
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Orzel (UFT+Leucovorin) as First-Line Therapy for Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Study Start Date: February 2000
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 lesions

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005608

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: William J. Gradishar, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00005608     History of Changes
Other Study ID Numbers: NU 99B3, NU-99B3, BMS-NU-99B3, NU-DRUG-BMS-ORZEL, NCI-G00-1741
Study First Received: May 2, 2000
Last Updated: May 31, 2012
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tegafur
Leucovorin
Levoleucovorin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on August 21, 2014