title: Phase I clinical trial of vinorelbine in tumor-bearing cats.
abstract: BACKGROUND
  Vinorelbine (VRL) has been investigated in dogs, but its use in cats has not been studied.
  
  
  OBJECTIVE
  To determine the maximal tolerated dose (MTD) and dose-limiting toxicity (DLT) of VRL in tumor-bearing cats.
  
  
  METHODS
  Cats were included in this prospective phase I trial if they had confirmed malignancy, received ≥1 VRL treatment, and had adequate follow-up. Previous treatment was acceptable, but concurrent chemotherapy or radiotherapy was not permitted.
  
  
  METHODS
  Using a modified phase I design, cats were enrolled in cohorts of 3 at a starting dosage of 9 mg/m(2) . Cats tolerating the first treatment well were eligible to receive additional VRL treatments at escalating dosages; escalations beyond the perceived MTD were permitted based on individual tolerance. Intended treatment interval was 7 days. Patient histories, physical examinations, and complete blood counts were performed weekly.
  
  
  RESULTS
  Nineteen cats were included. Sixty-one VRL treatments were administered. Median number of treatments was 2 (range, 1-9). Starting dosages were 9-12 mg/m(2) . Maximal dosage administered was 15.5 mg/m(2) . The MTD was 11.5 mg/m(2) . Acute DLTs were neutropenia, vomiting, and nephrotoxicity. Other notable toxicities were weight loss and anemia.
  
  
  CONCLUSIONS
  Vinorelbine is tolerated in cats at a weekly interval. Recommended starting dosage is 11.5 mg/m(2) . Neutropenia was transient, lasting <7 days; vomiting was self-limiting in most cases. Although VRL-associated nephrotoxicity has not been reported, potential attribution of this toxicity to VRL must not be discounted. Further investigation of the efficacy of VRL in feline malignancies is warranted.
authors.affiliation: Department of Small Animal Medicine and Surgery, College of Veterinary Medicine, University of Georgia, Athens, GA 30602, USA.
authors.forename: J A
authors.initials: JA
authors.lastname: Pierro
authors.forename: C L
authors.initials: CL
authors.lastname: Mallett
authors.forename: C F
authors.initials: CF
authors.lastname: Saba
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy / Q000662:veterinary*; D002371:Cat Diseases / Q000188:drug therapy*; D002415:Cats; D004305:Dose-Response Relationship, Drug; D005260:Female; D008297:Male; D034801:Mastocytoma / Q000188:drug therapy / Q000662:veterinary*; D012509:Sarcoma / Q000188:drug therapy / Q000662:veterinary*; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D000970:Antineoplastic Agents; D014747:Vinblastine; D000077235:Vinorelbine
keywords: Cancer; Chemotherapy; Feline; Navelbine