Phase I and Pharmacokinetic Study of IV Vinflunine in Combination With Carboplatin in Chemonaive Patients With Advanced Non-small Cell Lung Cancer
American Journal of Clinical Oncology, 07/20/2012
Tournoux–Facon C et al. – The combination of Vinflunine (VFL) (320mg/m2) and carboplatin AUC 5 given once every 3 weeks is established as the recommended dose (RD) of the combination, which was shown to be active in these chemonaive non–small cell lung cancer (NSCLC) patients.Methods
- This phase I and pharmacokinetic study was designed to determine the maximum tolerated dose and to establish the RD of VFL in combination with carboplatin.
- Twenty-one chemonaive patients with advanced NSCLC were treated with a first-line chemotherapy of VFL and carboplatin both given on day 1 every 3weeks with 3 dose levels.
- Five patients experienced a dose limiting toxicity consisting of constipation in 2 patients and febrile neutropenia in 2 patients.
- One patient experienced grade 3 abdominal pain concurrent with grade 4 neutropenia.
- The combination of VFL (320mg/m2) and carboplatin AUC6 was defined as the maximum tolerated dose.
- The RD was established at the dose of VFL (320mg/m2) combined with carboplatin AUC5.
- At the RD, 12 patients received a median number of 3 cycles of the combination.
- Neither VFL nor carboplatin seemed to be influencing the pharmacokinetics of the other.
- Among 19 patients evaluable for tumor response, 7 had a partial response and 7 experienced stable disease.