Intraperitoneal chemotherapy: Phase III trials

It is well documented that epithelial-type ovarian cancer growth remains within the intraperitoneal (IP) space for the majority of its natural history, making even advanced disease (e.g., stage III) amenable to regional therapy. The concept of IP delivery of chemotherapy goes back more than 40 years to the bioengineer, Robert Dedrick, whose research group at the National Institutes of Health developed animal and mathematical models to describe the disposition of cytotoxic agents administered directly into the IP space [1]. Most notably, his preclinical research led to the belly bath as a way of delivering cell-cycle specific agents by continuous 4 h infusions, leading to phase I/II clinical trials of IP 5-fluorouracil and methotrexate in patients with advanced ovarian cancer at the National Cancer Institute (NCI) [2, 3].