Spots Global Cancer Trial Database for Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally Advanced Head and Neck Cancer

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Trial Identification

Brief Title: Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally Advanced Head and Neck Cancer

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

Study ID: NCT00352105

Conditions

Head and Neck Cancer

Interventions

cisplatin

fluorouracil

Iressa

hyperfractionated radiation therapy

Study Description

Brief Summary: 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.

Detailed Description: 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.