Phase I and pharmacokinetic evaluation of the combination of orally administered docetaxel and cyclosporin A in tumor-bearing cats

J Vet Intern Med. 2006 Nov-Dec;20(6):1370-5. doi: 10.1892/0891-6640(2006)20[1370:piapeo];2.


Intravenously administered docetaxel (DT) is problematic in cats because of the requirement for premedication to ameliorate acute vehicle-induced hypersensitivity reactions. Previously we have revealed that therapeutic plasma concentrations of DT can be achieved in normal and tumor-bearing dogs when DT is administered PO in combination with oral cyclosporin A (CSA). The purpose of this study was to identify the maximally tolerated dosage and characterize the pharmacokinetic disposition of oral DT combined with CSA in cats with tumors. Eighteen tumor-bearing cats were enrolled in this phase I dose escalation and pharmacokinetic study. DT was administered by gavage with CSA (5 mg/kg) twice over a 3-week period. The starting dose of DT was 1.0 mg/kg. Based on the clinical toxicity profile, with gastrointestinal adverse effects and hematologic toxicity the maximal tolerated dose of oral DT was 1.75 mg/kg in combination with 5 mg/kg CSA. Additional studies are necessary to determine the efficacy of DT/CSA in cats with epithelial tumors.

Publication types

  • Clinical Trial, Phase I
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Animals
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / pharmacokinetics*
  • Area Under Curve
  • Cat Diseases / drug therapy*
  • Cats
  • Cyclosporine / adverse effects
  • Cyclosporine / pharmacokinetics*
  • Docetaxel
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Female
  • Male
  • Neoplasms / drug therapy
  • Neoplasms / veterinary*
  • Taxoids / adverse effects
  • Taxoids / pharmacokinetics*


  • Antineoplastic Agents
  • Taxoids
  • Docetaxel
  • Cyclosporine