A Phase II Pilot Study of SPI-77 (Stealth Liposomal Cisplatin) in Patients With Recurrent Platinum-Sensitive Ovarian Cancer
OBJECTIVES: I. Determine the objective response rate in patients with recurrent platinum
sensitive ovarian epithelial cancer treated with cisplatin liposomal (SPI-77). II. Determine
the time to response, duration of response, time to progression, and survival in these
patients treated with this regimen. III. Characterize the safety of this regimen in these
OUTLINE: Patients receive cisplatin liposomal (SPI-77) IV over a minimum of 4 hours on day
1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or
unacceptable toxicity. Patients with clinical benefit after 6 courses may receive additional
courses upon approval by the pharmaceutical sponsor. Patients are followed every 2 months
for a minimum of 6 months and then periodically for survival.
PROJECTED ACCRUAL: A total of 26-63 patients will be accrued for this study.
Primary Purpose: Treatment
Howard S. Hochster, MD
New York University School of Medicine
United States: Federal Government
|Kaplan Cancer Center||New York, New York 10016|