Phase I trial to study the effectiveness of docetaxel plus radiation therapy in treating patients who have stage III or stage IV head and neck cancer.
OBJECTIVES: * Determine the maximum tolerated dose of docetaxel when administered with concurrent boost radiotherapy in patients with advanced squamous cell carcinoma of the head and neck previously treated with induction chemotherapy. * Determine the toxicity of this treatment regimen in this patient population. * Determine the efficacy of this treatment regimen in these patients. OUTLINE: This is a dose escalation study of docetaxel. Patients receive docetaxel IV over 1 hour weekly for 4 weeks. Patients also undergo hyperfractionated radiotherapy daily, 5 days a week, for 4 weeks followed by radiotherapy alone twice daily for 2 weeks. Upon completion of chemoradiotherapy, patients not achieving complete response to induction chemotherapy undergo neck surgical dissection at 4-12 weeks following completion of radiotherapy. Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is reached. The MTD is the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose limiting toxicity. Additional patients are treated at the MTD. Patients are followed monthly for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
MTD of Taxotere
Time frame: 8 Weeks
Dose Limiting Toxicity
Time frame: 8 Weeks
Overall Response Rate
Time frame: 4-12 weeks post chemo/radiation therapy
Tumor Resistance Predictors
Tumor Biopsies and tissues
Time frame: Up to 1 year post chemo/radiation therapy
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