Breast Cancer Clinical Trial
Official title:
A Phase II Study Of An OutPatient Three Day VIP Regimen With Oral Mesna For Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells. Drugs
such as mesna may be effective in preventing some of the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of
etoposide and ifosfamide given with mesna, and cisplatin in treating patients who have
metastatic breast cancer.
OBJECTIVES:
- Determine the objective response rate in patients with metastatic breast cancer treated
with etoposide, ifosfamide with mesna, and cisplatin.
- Determine the tolerability and toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to number of prior chemotherapy courses for
metastatic disease (0 vs 1).
Patients receive etoposide IV over 60-90 minutes, cisplatin IV over 30 minutes, and
ifosfamide IV over 30 minutes on days 1-3. Mesna is administered IV over 15 minutes 30
minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion.
Treatment continues every 28 days in the absence of unacceptable toxicity or disease
progression.
Patients are followed every 3 months.
PROJECTED ACCRUAL: At least 36 patients (16 per stratum) will be accrued over 36 months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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