Purpose: The optimal dose of weekly paclitaxel in combination with carboplatin and concurrent radiation therapy (CRT) in patients with locally advanced non-small cell lung cancer (NSCLC) is not well defined in Japan. The purpose of this study was to define the maximum-tolerated dose (MTD) of paclitaxel in this combination.
Materials and methods: Treatment consisted of weekly paclitaxel plus carboplatin fixed AUC 2 and CRT for a total 60 Gy at 2 Gy/fraction/day 5 times weekly for 6 weeks. The dose of paclitaxel was 25 mg/m2 in the first cohort and escalated by 5 mg/m2 per cohort.
Results and conclusion: A total of 18 patients were enrolled and analyzed. The dose limiting toxicity of this study was considered to be pulmonary toxicity, and the MTD of it was determined to be 45 mg/m2 of paclitaxel in patients with NSCLC. Further evaluation of this regimen in a phase II trial is underway.