BACKGROUND: This phase I study of weekly low-dose administration of cisplatin (CDDP) and docetaxel (DOC) combined with concurrent conventionally fractionated radiotherapy was designed for locoregionally advanced head and neck cancer. PATIENTS AND METHODS: Twelve patients were treated at varying levels of DOC (level 1: 5 mg/m2/week, level 2: 7.5 mg/m2/week, level 3: 10 mg/m2/week) with CDDP constant at 20 mg/m2/week in four cohorts of three patients. Radiation was given at 1.8-2.0 Gy/fraction to a total dose of 60-70.2 Gy. RESULTS: Hematological toxicities, except lymphocytopenia, were minimal. Mucosal toxicities, especially grade 3 mucositis, were common. Dose-limiting toxicity was grade 3 pain, although level 3 did not reach a maximum tolerated dose. No grade 4 toxicities were observed. Complete response rate ranged from 33% to 67% in the various dose levels. CONCLUSION: This concurrent chemoradiotherapy seems to be a promising treatment modality, in which level 3 is the recommended dose for a phase II study.
BACKGROUND: This phase I study of weekly low-dose administration of cisplatin (CDDP) and docetaxel (DOC) combined with concurrent conventionally fractionated radiotherapy was designed for locoregionally advanced head and neck cancer. PATIENTS AND METHODS: Twelve patients were treated at varying levels of DOC (level 1: 5 mg/m2/week, level 2: 7.5 mg/m2/week, level 3: 10 mg/m2/week) with CDDP constant at 20 mg/m2/week in four cohorts of three patients. Radiation was given at 1.8-2.0 Gy/fraction to a total dose of 60-70.2 Gy. RESULTS:Hematological toxicities, except lymphocytopenia, were minimal. Mucosal toxicities, especially grade 3 mucositis, were common. Dose-limiting toxicity was grade 3 pain, although level 3 did not reach a maximum tolerated dose. No grade 4 toxicities were observed. Complete response rate ranged from 33% to 67% in the various dose levels. CONCLUSION: This concurrent chemoradiotherapy seems to be a promising treatment modality, in which level 3 is the recommended dose for a phase II study.