Head and Neck Cancer Clinical Trial
Official title:
Phase II Study of Paclitaxel and Cisplatin in Combination With Split Course Concomitant Hyperfractionated Re-Irradiation in Patients With Recurrent Squamous Cell Cancer of the Head and Neck
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the
number of immune cells found in bone marrow or peripheral blood and may help a person's
immune system recover from the side effects of chemotherapy. Radiation therapy uses
high-energy x-rays to damage tumor cells.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel, cisplatin, and filgrastim
combined with radiation therapy in treating patients who have locally recurrent head and
neck cancer and have received previous treatment with radiation therapy.
OBJECTIVES:
- Determine the median, one-year, and long-term (defined as two-year) disease-free
survival and overall survival in patients with previously irradiated locally recurrent
squamous cell cancer of the head and neck treated with paclitaxel, cisplatin, and
filgrastim (G-CSF) combined with radiotherapy.
- Determine the rates of acute and late toxic effects of this regimen in these patients.
- Determine the pattern of disease progression in patients treated with this regimen.
OUTLINE: Patients undergo radiotherapy twice daily (4-6 hours apart) on days 1-5. Patients
receive paclitaxel IV over 1 hour beginning immediately after completion of the first
fraction of radiotherapy and completing less than 3 hours before starting the second
fraction of radiotherapy on days 1-5. Patients receive cisplatin IV over 30 minutes
beginning immediately after completion of paclitaxel infusion on days 1-5 and filgrastim
(G-CSF) subcutaneously on days 6-13. Treatment repeats every 2 weeks for 4 courses in the
absence of disease progression or unacceptable toxicity. Patients who initially respond to
therapy but develop a recurrence with a resectable lesion (inside or outside the retreatment
field) may undergo surgical resection.
Patients are followed at 4 weeks after completion of radiotherapy, every 3 months for 2
years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 34 months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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