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Annals of Oncology 14:783-787, 2003
© 2003 European Society for Medical Oncology

Original Paper

Biweekly vinorelbine and gemcitabine: a phase I dose-finding study in patients with advanced solid tumors

D. Castellano+, R. Hitt, E. Ciruelos, H. Cortés-Funes and R. Colomer

Division of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain

Received 3 June 2002; revised 18 November 2002; accepted 3 December 2002

Background:

The purpose of this study was to determine the dose-limiting toxicity (DLT) and maximum tolerated dose of a combination of vinorelbine plus gemcitabine administered on a biweekly schedule in patients with advanced solid tumors.

Patients and methods:

Patients with advanced or refractory solid tumors included in this phase I study were treated with vinorelbine followed by gemcitabine. Vinorelbine was given intravenously over 10 min, and gemcitabine was given intravenously at an fixed-dose infusion rate of 10 mg/m2/min. Six dose levels of vinorelbine/gemcitabine were explored: 20/2000, 25/2500, 25/3000, 30/3000, 30/3500 and 30/2500 mg/m2.

Results:

Nineteen patients were included in the study. Fourteen patients were pretreated with chemotherapy and/or radiotherapy. A total of 123 cycles of chemotherapy were administered. DLTs were neutropenic fever and grade 3 asthenia at dose level 5 (30/3500 mg/m2); at dose level 4 (30/3000 mg/m2) they were grade 3 asthenia, and a radiation-recall reaction and pneumonitis. Sixteen patients were evaluable for efficacy. Five patients had an objective response (one complete response and four partial responses), for an overall response rate of 31%.

Conclusions:

The recommended dose for phase II study is vinorelbine 30 mg/m2 and gemcitabine 2500 mg/m2 administered once every 2 weeks. This regimen is feasible and well-tolerated at this dose, and shows a good clinical activity in all levels explored.

Key words: advanced solid tumors, biweekly schedule, gemcitabine, metastatic carcinoma, phase I trial, vinorelbine


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