Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
|Head and Neck Cancer||Drug: Taxotere Procedure: Surgery Radiation: radiation therapy||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT)|
- 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 [ Time Frame: Up to 1 year post chemo/radiation therapy ]Tumor Biopsies and tissues
|Actual Study Start Date:||July 14, 2000|
|Study Completion Date:||July 3, 2004|
|Primary Completion Date:||July 17, 2003 (Final data collection date for primary outcome measure)|
Other Name: DocetaxelProcedure: Surgery Radiation: radiation therapy
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006107
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Roy B. Tishler, MD, PhD||Dana-Farber Cancer Institute|