Continuous 5 Days Infusion of High Dose Ifosfamide and Adriamycin in Patients With Advanced Sarcoma
OBJECTIVES: I. Determine the response rate, time to treatment failure, and survival in
patients with advanced soft tissue or gynecological sarcoma treated with high-dose
ifosfamide and doxorubicin.
OUTLINE: Patients receive ifosfamide IV continuously on days 1-5 and doxorubicin IV on days
1-3. Filgrastim (G-CSF) is administered subcutaneously daily beginning 24 hours after
completion of ifosfamide infusion and continuing through day 16 (or until day 20 if blood
counts have not recovered by day 16). Courses repeat every 3 weeks in the absence of disease
progression or unacceptable toxicity. Patients are followed at treatment failure and then
annually thereafter.
PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Serge Leyvraz, MD
Study Chair
Centre Hospitalier Universitaire Vaudois
Switzerland: Swissmedic
SAKK 57/93
NCT00002526
January 1993
September 1995
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