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

Phase 1

Completed

Interventions: Drug: cisplatin
Drug: fluorouracil
Drug: Iressa
Radiation: hyperfractionated radiation therapy

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Concurrent Chemotherapy and ZD1839	cisplatin	-
Concurrent Chemotherapy and ZD1839	fluorouracil	-
Concurrent Chemotherapy and ZD1839	Iressa	-
Concurrent Chemotherapy and ZD1839	hyperfractionated radiation therapy	-

Primary Outcome Measures

Name	Time	Method
Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival	at 1 year after start of treatment	To explore the activity of ZD1839 with chemotherapy and hyperfractionated radiation using 1-year survival
Number of Participants With No Distant Metastatic Disease at 1 Year	1 year	1-year distant metastatic disease control in patients with locally advanced squamous cell head and neck cancer. Distant disease means that cancer came back in sites outside of the head and neck.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With No Local Disease at 1 Year	at 1 year after start of treatment	Number of Participants with No Local Disease at 1 Year. Local disease means that the cancer came back in the same site.
Number of Patients With Greater Than or Equal to Mild (Grade 1) Toxicity	at 1 year after start of treatment	Any toxicity greater than or equal to Grade 1= mild
Number of Patients With a Complete Response Defined as Complete Disappearance of All Clinically Detectable Tumor.	3 years	Complete response rate per RECIST Criteria (CTC V3)
Number of Participants Who Completed 2 Years of Therapy	at 2 years after start of treatment

Locations (1): Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
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Cleveland, Ohio, United States