title: Phase I and pharmacokinetic study of IV vinflunine in combination with gemcitabine for treatment of advanced non-small cell lung cancer in Chemonaive patients.
abstract: BACKGROUND
  Vinflunine (Javlor) has shown significant antitumour activity in advanced non-small cell lung cancer (NSCLC). We propose to define the recommended dose of vinflunine in combination with gemcitabine for treatment of advanced NSCLC in chemonaive patients.
  
  
  METHODS
  A phase I and pharmacokinetic study was conducted to determine the maximum tolerated dose and to establish the recommended dose of vinflunine (VFL) administered on day 1 every 21 days combined with gemcitabine given on days 1 and 8 every 3 weeks.
  
  
  RESULTS
  Nineteen patients were included in this study. Three patients experienced a dose limiting toxicity, with constipation in one patient, hypertension in one patient, and constipation and febrile neutropenia in one patient. The combination of VFL 320 mg/m² and gemcitabine 1250 mg/m² was defined as the maximum tolerated dose. The recommended dose was established at the dose of VFL 320 mg/m² combined with gemcitabine 1000 mg/m². Neither VFL nor gemcitabine seemed to be influencing the pharmacokinetics of each other. All patients were evaluable for tumor response. Seven presented a partial response and eight experienced a stable disease.
  
  
  CONCLUSIONS
  The combination of VFL 320 mg/m² administered on day 1 combined with gemcitabine 1000 mg/m² given on days 1 and 8 every 3 weeks is established as the RD and was shown to be active in these chemonaive NSCLC patients.
authors: Centre Hospitalier Universitaire-Pôle Régional de Cancérologie-CIC P802, Poitiers, France.
authors: Caroline
authors: C
authors: Tournoux-Facon
authors: Hélène
authors: H
authors: Senellart
authors: Etienne
authors: E
authors: Lemarie
authors: Jean Marc
authors: JM
authors: Tourani
authors: Stéphanie
authors: S
authors: Favrel
authors: Jean Christophe
authors: JC
authors: Pouget
authors: Marie Claire
authors: MC
authors: Pinel
authors: Jaafar
authors: J
authors: Bennouna