A Phase I Study of Fludarabine With Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of Fludarabine During Sixth & Seventh Weeks of Radiotherapy
MTD based on systemic toxicity of drug and acute mucosal reactions in the irradiated fields.
Every 4 weeks
K. Kian Ang, MD, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|