Safety Evaluation of Low-Dose Meloxicam with Toceranib Phosphate (Palladia) in Cancer-Bearing Cats: A Phase I Dose-Finding Study
Introduction
Palladia is used to treat several feline cancers. NSAIDs are infrequently utilized in cats due to concern for renal compromise; however, recent studies demonstrate tolerability of low-dose meloxicam. The goal of this study was to determine the maximum tolerated dose and adverse event profile of combined Palladia and meloxicam in cancer-bearing cats. Secondary goals were to assess anti-cancer tumor efficacy and impact upon quality of life and analgesia.
Methods
Cats with any cancer not involving the kidneys were eligible. The study adopted a conventional 3+3 cohort design. Palladia was administered every other day at standard dose with meloxicam administered in an escalating fashion, at a starting dose of 0.01 mg/kg on days opposite of Palladia. Lab work, blood pressure, tumor measurements, pain score, and client-completed quality of life surveys were recorded every 2–4 weeks during the 3-month study period.
Results
Fifteen cats have been enrolled in the study to date. The MTD of meloxicam when combined with Palladia has not yet been reached, but it is at least 0.01 mg/kg every other day with no cats being withdrawn due to adverse events from the drug combination. The majority of cats have demonstrated clinical benefit with stable to mildly improved tumor measurements, quality of life, and pain scores.
Conclusion
Preliminary data indicate that low-dose meloxicam combined with Palladia is safe and well-tolerated in cancer-bearing cats. Continued patient recruitment and data collection is needed to determine the maximum tolerated dose of meloxicam. The results of our study will guide further Phase II/III trials.
Funding Information
Funding for this study has been provided by the VCS Resident Grant.