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Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer Clinical research trials and Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer. Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer  Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer
Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Robert H. Lurie Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamGradishar, Study Chair, Robert H. Lurie Cancer Center
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
Additional Information:
Study ID Numbers: CDR0000067733; NU-DRUG-BMS-ORZEL,NU-99B3,NCI-G00-1741,BMS-NU-99B3
Study Start Date: February 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005608
Other Recurrent Breast Cancer Studies:
1. Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer
2. Bevacizumab in Treating Patients With Metastatic Breast or Colorectal Cancer Who Received Bevacizumab on a Phase II or Phase III Clinical Trial
3. Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline and/or a Taxane
4. Combination Chemotherapy With Trastuzumab in Treating Women With Metastatic Breast Cancer
5. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Advanced Breast Cancer
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Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer
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