Docetaxel Followed by Gemcitabine in the Treatment of Advanced Non-small Cell Lung Cancer: A Phase I Study

Abstract

Aims and Background

Based on the results of a preclinical study, a phase I trial was conducted to evaluate the feasibility of administering docetaxel followed by gemcitabine in non-small cell lung cancer patients.

Study design

Sixteen patients with advanced non-small cell lung cancer (stages III B-IV) were treated on the 1^st day with docetaxel and on the 8^th day with gemcitabine. Treatment was repeated every three weeks for a maximum of six cycles. Five groups received docetaxel/gemcitabine (mg/m²): 50/800, 60/800, 60/900, 60/1,000, 70/1,000. All patients and 57 cycles were assessed for toxicity.

Results

The most important side effects were grade IV neutropenia in 4 patients (2 at the 60/1000 level and 2 at the 70/1000 level) and grade III leukopenia and neutropenia without fever in 4 and 6 patients, respectively. Maximum tolerated dose was not reached.

Conclusions

The sequence docetaxel → gemcitabine appears well tolerated and easy to administer. For this reason, a phase II study is ongoing to fully assess its antitumor activity.