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Principal Investigator: Margaret McEntee
Co-Investigators: Kenneth Rassnick, Dennis Bailey & Cheryl Balkman
Contact Information: E-mail: mcm43@cornell.edu - Phone: 607-253-3208
Sponsor: Morris Animal Foundation
Grant Number: D07FE-016
Title: Phase II Study of Oral Docetaxel and Cyclosporine in Feline Epithelial Cancer
Annual Direct Cost: $36,425
Project Period: 11/1/07-10/31/09
DESCRIPTION (provided by applicant): Our goal is to define the role of oral docetaxel (DT) in feline cancer treatment. Although the oral bioavailability of docetaxel alone is poor, it is significantly improved by co-administration with cyclosporine A (CsA), and therapeutic serum levels are achieved in humans, rodents, dogs and cats. In a normal beagle study it was determined that the bioavailability of oral docetaxel alone was 6.7%, and increased to 98.8% when combined with cyclosporin A. These results provided an opportunity to initiate a systematic evaluation of docetaxel. This compound is the most active chemotherapeutic agent developed in the last 10 years and is rarely used in veterinary oncology due to hypersensitivity reactions following conventional intravenous dosing. A Phase I dose escalation trial in client owned cats with spontaneous tumors was completed to determine the maximally tolerated dose (MTD) of orally administered docetaxel in combination with cyclosporine A. Cats with any type of epithelial cancer will be eligible for entry in the Phase II study proposed here. Plasma DT values will be evaluated at one time point after drug administration to characterize systemic drug exposure. Each cat will receive two doses of DT/CsA at 2-week intervals and be monitored for hematologic and gastro-intestinal toxicity, and response to therapy.
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