Expansion cohort and pharmacokinetic modeling of oxaliplatin in dogs with spontaneous solid tumors

Purpose

To determine acute and cumulative dosing safety of the chemotherapy drug oxaliplatin in dogs with cancer, and to measure the preliminary effectiveness of the drug.

Background

The human chemotherapy drug oxaliplatin shows promise of being less toxic and more effective than current canine cancer therapies, but additional studies are needed to establish a safe and effective dose for veterinary use. We’ve previously studied this drug in a small cohort of dogs with cancer, and no dose-limiting toxicities were found. In this study, we’ll expand the number of dogs enrolled to further our understanding of the acute and cumulative effects of oxaliplatin in dogs with cancer.

Eligibility

  • Dogs must weigh > 10 kg. / 22 lbs.
  • Biopsy-confirmed diagnosis of solid tumor
  • Owner willingness to comply with follow-up visit schedule

Exclusion

  • Other serious life-limiting disease (such as heart, liver, or renal failure)
  • Diagnosis of non-solid tumor such as lymphoma, leukemia, or mast cell tumor
  • Expected survival of < 6 weeks without treatment due to metastatic disease
  • Dogs must not have received conventional chemotherapy for the past 3 weeks or radiation therapy for the past 4 weeks before beginning treatment

Study Design

A complete physical exam, including relevant diagnostic imaging, will be undertaken to determine eligibility. Once enrolled, dogs will be given a dose of oxaliplatin intravenously over the course of several hours on Days 1 and 21 of the study. Please note that dogs will be hospitalized and monitored overnight following their first infusion of the drug.

Optional additional doses of oxaliplatin may be provided at owner cost, if the drug is well-tolerated and appears to be effective. Owners will be asked to keep a brief, weekly record of any side effects or changes in the dog’s behavior during the course of the study. Recheck appointments will be scheduled as follows:

  • Blood draw at 2-3 days after first treatment
  • Week 1 evaluation
  • Week 2 evaluation
  • Week 3 evaluation
  • Week 4 evaluation
  • Week 5 evaluation
  • Week 6 evaluation

Compensation

The study will cover the cost of study-related visits, lab work, and two chemotherapy treatments. The estimated value of these services is $2,500-3,000. Owners are responsible for the cost of the initial screening visit prior to enrollment and a restaging exam at 6 weeks following treatment. Total out-of-pocket expenses are approximately $1,300-1,900.

Contact

Mindy Quigley, Clinical Trials Coordinator
Office Phone: 540-231-1363 | Email: vettrials@vt.edu

Dr. Shawna Klahn, Associate Professor, Oncology
Phone: 540-231-4621 | Email: shawnalk@vt.edu

If your query is urgent, please call the Small Animal Hospital on 540-231-4621 and ask for the oncologist on duty.