A Phase II Study Of An OutPatient Three Day VIP Regimen With Oral Mesna For 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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.
Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
No
Scot C. Remick, MD
Principal Investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
CWRU4196
NCT00006260
May 1997
Name | Location |
---|---|
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |