Study Start Date: 11/01/2007
Study End Date: 3/31/2011

Phase II evaluation of oral docetaxel in cats with carcinomas

A study funded by the Morris Animal Foundation is being conducted at Cornell University on the use of orally administered docetaxel in cats with carcinomas (epithelial tumors). Docetaxel is one of the most effective human anticancer drugs, and a high response rate has been observed in dogs with oral squamous cell carcinoma. In human oncology, docetaxel typically is given intravenously. However, when docetaxel is given intravenously one of the inert substances used to improve drug solubility (polysorbate 80) causes allergic reactions. This has significantly limited its use in veterinary oncology. Oral bioavailability of docetaxel is low, but when cyclosporine is given concurrently the oral bioavailability of docetaxel dramatically improves. Allergic reactions are avoided as well. A previous study has been completed determining the maximum safe dose of oral docetaxel as a prelude to the current study. Now we are treating cats with docetaxel at this dosage to evaluate its efficacy against various epithelial cancers, specifically targeting oral squamous cell carcinoma. Two doses of docetaxel are administered two weeks apart to determine response. The study covers the cost of the drug, administration, recheck blood work and evaluations, and if there are side effects (primarily gastrointestinal) that require hospitalization. If a positive response is observed, additional chemotherapy doses can be considered with partial funding available.

Study Design:
Prospective

Sample Size:
30 cats

Inclusion Criteria:

• Patient needs to be referred to Cornell University for treatment
• Histologically confirmed carcinoma of any type. (Note: Cats can be referred if carcinoma is suspected but not confirmed, and a biopsy can be performed at Cornell prior to enrollment into the study.)
• Measurable tumor volume based on physical examination and/or imaging (thoracic radiographs, abdominal ultrasound, CT, etc). This can be the primary tumor, metastatic disease, or a combination.
• No previous treatment within 3 weeks of starting docetaxel.
• Life expectancy of at least 1 month.

Exclusion Criteria:
Concurrent disease (such as chronic renal failure or cardiac disease) is not an automatic exclusion criteria, but each patient's overall quality of life will be considered before making a final decision regarding eligibility.

Study Controls:
Not applicable

Study Endpoints:
The primary endpoint is to determine the efficacy of orally-administered docetaxel against various carcinomas, particularly oral squamous cell carcinoma. A secondary endpoint will be to continue to gather information regarding potential adverse effects associated with orally administered docetaxel.

Samples:
No samples will be submitted.

Costs/Reimbursements:
The study covers the cost of the drug, administration, recheck blood work and evaluations, any imaging needed to assess response to therapy, and any costs incurred if the patient experiences any adverse effects associated with treatment (primarily gastrointestinal). If a positive response is observed, additional chemotherapy doses can be considered with partial funding available. Please note that funding will pay for any expenses incurred at Cornell, but unfortunately we are not able to reimburse expenses incurred elsewhere.

Full Disclosure information:

• The study is funded by a grant from Morris Animal Foundation.
• The investigators do not have a conflict of interest.
• The study will be published if results are negative.
• The study will be reported on VIN.
• The authors will acknowledge VIN if the study is published.