Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
Recruitment status was Active, not recruiting
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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 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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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:
- 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.
Eligibility| Ages Eligible for Study: | 75 Years to 90 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| Centre Hospitalier Victor Dupouy | |
| Argenteuil, France, 95107 | |
| Polyclinique De Courlancy | |
| Metz, France, 55038 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| C.H. Senlis | |
| Senlis, France, 60309 | |
| Centre Medico-Chirurgical Foch | |
| Suresnes, France, 92151 | |
| Study Chair: | Elisabeth Carola, MD | C.H. Senlis |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00010075 History of Changes |
| Other Study ID Numbers: | CDR0000068439, FRE-GERCOR-SAM-S99-1, EU-20028 |
| Study First Received: | February 2, 2001 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV breast cancer recurrent breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fluorouracil Mitoxantrone Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013