Liposomal Cisplatin in Treating Patients With Recurrent Ovarian Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of liposomal cisplatin in treating patients who have recurrent ovarian cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Pilot Study of SPI-77 (Stealth Liposomal Cisplatin) in Patients With Recurrent Platinum-Sensitive Ovarian Cancer|
|Study Start Date:||February 1999|
|Primary Completion Date:||December 1999 (Final data collection date for primary outcome measure)|
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.
|United States, New York|
|Kaplan Cancer Center|
|New York, New York, United States, 10016|
|Study Chair:||Howard S. Hochster, MD||New York University School of Medicine|