Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
Recruitment status was: Active, not recruiting
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.
Drug: leucovorin calcium
Drug: mitoxantrone hydrochloride
|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|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010075
|Centre Hospitalier Victor Dupouy|
|Argenteuil, France, 95107|
|Polyclinique De Courlancy|
|Metz, France, 55038|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Paris, France, 75970|
|Senlis, France, 60309|
|Centre Medico-Chirurgical Foch|
|Suresnes, France, 92151|
|Study Chair:||Elisabeth Carola, MD||C.H. Senlis|