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
patients.
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.
Interventional
Primary Purpose: Treatment
Howard S. Hochster, MD
Study Chair
New York University School of Medicine
United States: Federal Government
CDR0000067294
NCT00004083
February 1999
Name | Location |
---|---|
Kaplan Cancer Center | New York, New York 10016 |