Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer

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Trial Identification

Brief Title: Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer

Official Title: Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women

Study ID: NCT00010075

Conditions

Breast Cancer

Interventions

fluorouracil

leucovorin calcium

mitoxantrone hydrochloride

Study Description

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.