A Phase I Study of Intraperitoneal Oxaliplatin Alone and in Combination With Intraperitoneal Floxuridine and Leucovorin in Patients With Advanced Metastatic Cancer Confined to the Peritoneal Cavity
- Determine the maximum tolerated dose of intraperitoneal oxaliplatin with or without
intraperitoneal floxuridine and leucovorin calcium in patients with metastatic cancer
confined to the peritoneal cavity.
- Determine dose limiting and nondose limiting toxicities and pharmacokinetics of these
treatment regimens in this patient population.
OUTLINE: This is a dose escalation study of oxaliplatin.
Patients receive intraperitoneal (IP) oxaliplatin over 1 hour on day 1 every 2 weeks for 2
Beginning at course 3, patients receive oxaliplatin with floxuridine and leucovorin calcium
IP on day 1 and floxuridine and leucovorin calcium IP alone on days 2 and 3. Treatment
repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
Patients with complete surgical resection of disease receive a total of 6 courses of
Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: A total of 3-40 patients will be accrued for this study.
Primary Purpose: Treatment
Leonard B. Saltz, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|