Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women
75 Years
90 Years
Female
Breast Cancer
Trial Information
Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women
OBJECTIVES:
- Determine the survival without degradation of quality of life in elderly women with
metastatic breast cancer treated with leucovorin calcium, fluorouracil, and
mitoxantrone.
- Determine the efficacy of this regimen, in terms of response and survival without
progression, in these patients.
- Determine the tolerance of these patients to this regimen.
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic adenocarcinoma of the breast
- Bidimensionally measurable or evaluable disease
- At least one non-irradiated lesion that is at least 2 cm in the greater diameter
OR
- Serous drainage, cutaneous metastasis, osseous metastasis, etc.
- No symptomatic cerebral metastasis
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 75 to 90
Sex:
- Female
Menopausal status:
- Postmenopausal
Performance status:
- WHO 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Platelet count at least 100,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
Hepatic:
- Alkaline phosphatase less than 3 times normal
- Bilirubin less than 1.5 times normal
- Transaminases less than 3 times normal
- Total protein greater than 60%
- Albumin greater than 30 g/L
Renal:
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- LVEF greater than 50% by echocardiogram or scintigraph
- ECG normal
- No uncontrolled angina
- No myocardial infarction within past 6 months
Other:
- No other medical illness or condition that would preclude study
- No other prior malignancy except basal cell skin cancer or curatively treated
carcinoma in situ of the cervix
- No psychological, social, familial, or geographical reasons that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Prior adjuvant chemotherapy allowed
- No prior adjuvant anthracyclines
- No prior chemotherapy for metastatic disease
Endocrine therapy:
- One or two prior regimens of hormonal therapy allowed for metastatic disease
Radiotherapy:
- No prior radiotherapy for metastatic disease
Surgery:
- Not specified
Other:
- No concurrent participation in another study
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Elisabeth Carola, MD
Investigator Role:
Study Chair
Investigator Affiliation:
C.H. Senlis
Authority:
United States: Federal Government
Study ID:
CDR0000068439
NCT ID:
NCT00010075
Start Date:
January 2000
Completion Date:
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
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