Published results can be found here.

Study Start Date: 09/08/2008
Study End Date: 05/01/2009

Phase I Intravenous Docetaxel Treatment of Cats.

Docetaxel is a taxane chemotherapy drug which is used in humans for metastatic breast and head/neck carcinomas. The purpose of this study is to identify a safe dose of intravenous docetaxel administration. Cats with ANY histologically diagnosed neoplasm (gross or microscopic disease) may be eligible. This trial may be of particular interest for cats with incompletely excised vaccine associated sarcomas, malignant/metastatic mammary carcinomas and oral squamous cell carcinomas. The initial cohort that has been filled has been well tolerated.

Study Design:
Prospective Phase I clinical trial.

Inclusion Criteria:

• Entry Requirements: Cats with any histologically confirmed, measurable malignant tumor that have either failed standard of care treatment, declined other treatment options, or for which there is no established standard of care.
• Must have a life expectancy of at least 12 weeks.
• Must be free of significant underlying medical disease and have a VCOG performance status of 0 or 1, and bilirubin and creatinine levels within 1.5X normal.
• Albumin within 80% of lower limit of normal.
• Prior chemotherapy is allowed with at least a 3-week washout period before entering this study.
• No concurrent chemotherapy or radiation therapy.
• Obtain signed informed owner consent and consent to necropsy forms.
• Patients must be presented to University of Wisconsin-Madison.

Exclusion Criteria:

• Cats not meeting inclusion criteria (above).

Study Controls:
none

Study Endpoints:
Poor quality of life, progressive disease, grade IV toxicity, client or clinician withdrawal for any reason.

Costs/Reimbursements:
Owners are responsible for the cost of the initial staging (approximately $400-600). The study will then pay for all costs related to docetaxel treatment and follow-up imaging and evaluations for 5 treatments (excluding nominal examination charges of approximately $35 per visit).  All administrative and treatment costs at the UW Madison VMTH (except initial staging, complications and nominal examination fees) are paid by the study.

Full Disclosure information:

• The study is funded by a grant from the Animal Cancer Fund.
• The investigator does 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 if a significant proportion (>3) of patients are enrolled directly as a result of VIN promotion.