Taxotere Plus Concurrent Radiotherapy After Induction Chemotherapy for Squamous Cell Carcinoma of the Head and Neck (TAXT-XRT)
OBJECTIVES: I. Determine the maximum tolerated dose of weekly docetaxel when administered as
concurrent therapy with radiation therapy after treatment with induction chemotherapy in
patients with squamous cell carcinoma of the head and neck. II. Determine the toxicity
profile of this regimen in these patients. III. Obtain preliminary assessment of the
efficacy of this regimen in these patients. IV. Study potential predictors of tumor
resistance prospectively through tumor biopsies and tissues.
OUTLINE: This is a dose escalation study. Patients are administered 1 hour IV infusions of
docetaxel weekly for 6 weeks concurrently with radiation therapy 5 days a week for 6 weeks.
Patients are treated in cohorts of 3-5 patients per dose. An entire cohort must complete
treatment at a given dose level before a new cohort is accrued at a higher dose. The maximum
tolerated dose (MTD) is the dose level below that at which dose limiting toxicity occurs in
2 of 5 patients. At the MTD, 15 additional patients are treated to assess for toxicity.
Patients are followed every 3 months until disease progression or death.
PROJECTED ACCRUAL: A maximum of 35 patients is accrued into this study.
Primary Purpose: Treatment
Marshall R. Posner, MD
Dana-Farber Cancer Institute
United States: Federal Government
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Harvard Community Health Plan||Boston, Massachusetts 02215|