Phase I Trial Intraperitoneal Cisplatin With Intraperitoneal Gemcitabine in Patients With Epithelial Ovarian Carcinoma
OBJECTIVES: I. Determine the maximum tolerated dose of intraperitoneal (IP) gemcitabine
given in combination with IP cisplatin in patients with refractory or recurrent ovarian
epithelial, fallopian tube, or primary peritoneal cancer. II. Determine the safety of this
regimen in this patient population. III. Determine the pharmacokinetics of IP gemcitabine
administered with IP cisplatin.
OUTLINE: This is a dose escalation study of gemcitabine. Patients receive intraperitoneal
cisplatin on day 1 plus intraperitoneal gemcitabine on days 1, 8, and 15. No treatment will
be given on day 22. Courses are repeated every 4 weeks. Patients receive up to 4 courses of
therapy. Dose escalation of gemcitabine continues in cohorts of 3 patients until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2
of 6 patients experience dose limiting toxicity (DLT). Patients are followed every 3 months
for 2 years, then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued for this study.
Primary Purpose: Treatment
Paul Sabbatini, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|