Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally Advanced 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.
|Head and Neck Cancer||Drug: cisplatin Drug: fluorouracil Drug: Iressa Radiation: hyperfractionated radiation therapy||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival [ Time Frame: 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 [ Time Frame: 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.
- Number of Participants With No Local Disease at 1 Year [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 3 years ]Complete response rate per RECIST Criteria (CTC V3)
- Number of Participants Who Completed 2 Years of Therapy [ Time Frame: at 2 years after start of treatment ]
|Study Start Date:||April 2006|
|Study Completion Date:||May 2010|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
|Experimental: Concurrent Chemotherapy and ZD1839||
20mg/m2/d IV continuous infusion x4 days
Other Name: CDDPDrug: fluorouracil
1000mg.m2/d IV continuous x 4 days
Other Name: 5FUDrug: Iressa
250mg/PO qd x 2 years
Other Name: ZD1839Radiation: hyperfractionated radiation therapy
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352105
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||David J. Adelstein, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|