A Phase I Trial of Docetaxel Based Induction and Concomitant Chemotherapy in Patients with Locally Advanced Head and Neck Cancer

Abstract

The purpose of this study was to determine the maximum tolerated dose (MTD) of docetaxel based induction and concomitant chemoradiotherapy (CRT) after using the FHX platform (5 = 5-FU, H = hydroxyurea, X = Radiation). Patients with Stage III/IV locally advanced HNSCC were enrolled. Induction chemotherapy (carboplatin/docetaxel) was followed by 5 cycles of concomitant docetaxel based CRT. No DLTs were observed in dose levels 1/2 for induction and CRT. Dose level 2 was expanded. The overall survival CR rate after CRT was 79 percent. Median overall (OS) has not been reached and 2-year OS is 80.7 percent. The recommended Phase II dose of docetaxel with FHX CRT is 25 mg/m² and 35 mg/m² in combination with carboplatin induction (AUC = 6).

Keywords:

• Phase I
• Locally Advanced Head and Neck Cancer
• Docetaxel
• Chemoradiotherapy
• Induction Chemotherapy
• 5-FU
• Hydroxyurea