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

INTRODUCTION:

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: Caroline Tournoux-Facon, Hélène Senellart, Etienne Lemarie, Jean Marc Tourani, Stéphanie Favrel, Jean Christophe Pouget, Marie Claire Pinel, Jaafar Bennouna
• Journal: Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer (J Thorac Oncol) Vol. 6 Issue 7 Pg. 1247-53 (Jul 2011) ISSN: 1556-1380 [Electronic] United States
• PMID: 21610520 (Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study)

Chemical References

• Deoxycytidine
• vinflunine
• Vinblastine
• Gemcitabine

Topics

• Adenocarcinoma (drug therapy, secondary)
• Aged
• Antineoplastic Combined Chemotherapy Protocols (pharmacokinetics, therapeutic use)
• Carcinoma, Large Cell (drug therapy, secondary)
• Carcinoma, Non-Small-Cell Lung (drug therapy, secondary)
• Carcinoma, Squamous Cell (drug therapy, secondary)
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Female
• Follow-Up Studies
• Humans
• Lung Neoplasms (drug therapy, pathology)
• Lymphatic Metastasis
• Male
• Maximum Tolerated Dose
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy, pathology)
• Neoplasm Staging
• Survival Rate
• Tissue Distribution
• Treatment Outcome
• Vinblastine (administration & dosage, analogs & derivatives)
• Gemcitabine