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
- 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
- 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
Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival
To explore the activity of ZD1839 with chemotherapy and hyperfractionated radiation using 1-year survival
at 1 year after start of treatment
David J. Adelstein, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|