Ovarian Cancer Clinical Trial
Official title:
Continuous 5 Days Infusion of High Dose Ifosfamide and Adriamycin in Patients With Advanced Sarcoma
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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of
ifosfamide and doxorubicin 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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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