Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00010075
- Lead Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Hopital Tenon
🇫🇷Paris, France
Centre Hospitalier Victor Dupouy
🇫🇷Argenteuil, France
Hopital Saint Antoine
🇫🇷Paris, France
Polyclinique De Courlancy
🇫🇷Metz, France
C.H. Senlis
🇫🇷Senlis, France
Centre Medico-Chirurgical Foch
🇫🇷Suresnes, France