Phase I Trial of Taurolidine After Positive Second Look Surgery for Recurrent Ovarian Epithelial, Fallopian Tube and Primary Peritoneal Cancers
OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of
taurolidine after positive second-look surgery in patients with recurrent ovarian, fallopian
tube, or primary peritoneal cancer. II. Determine the dose-limiting toxicity and safety of
this drug in these patients.
OUTLINE: This is a dose-escalation study. Patients receive taurolidine intraperitoneally
weekly on weeks 1-3 and 7-9 in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of taurolidine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 6 patients experience dose-limiting toxicity. Patients are followed every 3 weeks for 9
PROJECTED ACCRUAL: A maximum of 15 patients will be accrued for this study within 12-18
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|