Breast Cancer Clinical Trial
Official title:
Docetaxel (DTX) - Ifosfamide (IFX) As First Line Chemotherapy In Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of docetaxel and ifosfamide in treating
women who have metastatic breast cancer.
OBJECTIVES:
- Determine the efficacy of docetaxel and ifosfamide as first-line chemotherapy in women
with metastatic breast cancer.
- Determine the response rate and duration of response of patients treated with this
regimen.
- Determine the time to treatment failure and survival of patients treated with this
regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on day 1 and ifosfamide IV over 1 hour (beginning
1 hour after docetaxel infusion) on days 1-3. Treatment continues every 4 weeks in the
absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every month during study, and then every 3 months
after completion of study.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 15-42 patients will be accrued for this study.
;
Primary Purpose: Treatment
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