Head and Neck Cancer Clinical Trial
Official title:
A Phase I/II Trial of Concurrent Chemotherapy and ZD1839 (IRESSA) With Hyperfractionated Radiation Therapy, Followed by Maintenance ZD1839 (IRESSA) for Patients With Locally Advanced Squamous Cell Head and Neck Cancer
RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells.
Giving cisplatin, fluorouracil, and gefitinib together with radiation therapy may kill more
tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin,
fluorouracil, and gefitinib together with hyperfractionated radiation therapy and to see how
well they work in treating patients with locally advanced head and neck cancer.
OBJECTIVES:
Primary
- Explore the activity of cisplatin, fluorouracil, gefitinib, and hyperfractionated
radiotherapy, in terms of 1-year survival and 1-year distant metastatic disease
control, in patients with locally advanced squamous cell carcinoma of the head and
neck.
Secondary
- Explore the activity of this regimen, in terms of disease-specific survival and local
control, in these patients.
- Assess the toxicity of this regimen in these patients.
- Assess the complete response rate in patients treated with this regimen.
- Assess the toxicity and tolerability of long-term maintenance with gefitinib in
patients rendered disease free after this treatment regimen.
OUTLINE: Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week,
beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IV
continuously over 96 hours and cisplatin IV continuously over 96 hours on days 1-4 and 22-25
and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-6 months.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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