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Sponsored by: |
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00010075 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older women who have metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: fluorouracil Drug: leucovorin calcium Drug: mitoxantrone hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women |
Study Start Date: | January 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive mitoxantrone IV and leucovorin calcium IV over 2 hours on day 1. Patients then receive fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, after 3 courses, and at treatment completion.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Ages Eligible for Study: | 75 Years to 90 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Bidimensionally measurable or evaluable disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
France | |
C.H. Senlis | |
Senlis, France, 60309 | |
Centre Hospitalier Victor Dupouy | |
Argenteuil, France, 95107 | |
Centre Medico-Chirurgical Foch | |
Suresnes, France, 92151 | |
Polyclinique De Courlancy | |
Metz, France, 55038 | |
Hopital Tenon | |
Paris, France, 75970 | |
Hopital Saint Antoine | |
Paris, France, 75571 |
Study Chair: | Elisabeth Carola, MD | C.H. Senlis |
Study ID Numbers: | CDR0000068439, FRE-GERCOR-SAM-S99-1, EU-20028 |
Study First Received: | February 2, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00010075 |
Health Authority: | United States: Federal Government |
stage IV breast cancer recurrent breast cancer |
Calcium, Dietary Skin Diseases Fluorouracil Leucovorin Quality of Life |
Breast Neoplasms Mitoxantrone Breast Diseases Recurrence |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Sensory System Agents Therapeutic Uses Vitamins Peripheral Nervous System Agents Analgesics Micronutrients Central Nervous System Agents |