A dose-finding study with a novel water-soluble formulation of paclitaxel for the treatment of malignant high-grade solid tumours in dogs

Vet Comp Oncol. 2013 Dec;11(4):243-55. doi: 10.1111/j.1476-5829.2011.00314.x. Epub 2012 Mar 9.

Abstract

A new formulation of water-soluble paclitaxel (Paccal® Vet) has been developed for canine cancer patients, without the need for pre-medication (traditionally required in non-water-soluble paclitaxel formulations). The objective of the study was to determine a clinically safe and efficacious dose of Paccal Vet and to estimate progression-free and overall survival and to evaluate single-dose pharmacokinetics in tumour-bearing dogs. A positive risk:benefit ratio was established for Paccal Vet administered at 150 mg m(-2) intravenous (IV) for three or more treatment cycles. Preliminary efficacy was demonstrated by best objective response rate (86%), median time to response (14 days) and median progression-free survival (131 days). Paccal Vet was associated with expected adverse events (AE) (e.g. myelosuppression), however the majority were transient, clinically silent and manageable. This is the first clinical report of a water-soluble formulation of paclitaxel suggesting successful administration and being safely used without pre-medication in dogs.

Keywords: cancer; canine; malignant; paclitaxel; translational oncology; tumour.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Antineoplastic Agents, Phytogenic / administration & dosage
  • Antineoplastic Agents, Phytogenic / pharmacology*
  • Dog Diseases / drug therapy*
  • Dogs
  • Dosage Forms
  • Female
  • Male
  • Neoplasms / drug therapy
  • Neoplasms / pathology
  • Neoplasms / veterinary*
  • Paclitaxel / administration & dosage
  • Paclitaxel / pharmacology*
  • Survival Analysis

Substances

  • Antineoplastic Agents, Phytogenic
  • Dosage Forms
  • Paclitaxel