Head and Neck Cancer Clinical Trial
Official title:
A Phase I Study of Fludarabine With Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
die. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus fludarabine in
treating patients who have locally advanced cancer of the mouth, pharynx, or larynx.
OBJECTIVES: I. Determine the maximum tolerated dose of fludarabine that can be given during
the sixth and seventh weeks of radiotherapy in patients with locally advanced squamous cell
carcinoma of the oral cavity, pharynx, or larynx, based on the systemic toxicity of the drug
and the acute mucosal reactions in the irradiated fields. II. Document the qualitative and
quantitative toxicity of this combination therapy in this patient population.
OUTLINE: This is a dose escalation study of fludarabine. Patients receive radiotherapy on
days 1-5 for 7 weeks. Patients receive fludarabine IV on days 1-5 of weeks 6 and 7 of
radiotherapy. Fludarabine is administered 3-4 hours prior to daily radiotherapy. Cohorts of 3
patients receive escalating doses of fludarabine until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose that produces a severe toxicity rate nearest to
20%. Patients are followed every 4 weeks after the completion of treatment until acute
reactions have resolved, then every 3 months for 2 years, every 4 months for 1 year, and then
every 6 months for 2 years.
PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for this study within 1.5 years.
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