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.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 2010 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed primary* squamous cell carcinoma of the head and neck region, excluding any of the following: - Nasopharynx - Paranasal sinuses - Salivary glands NOTE: *Primary site must be identified - Locoregionally confined stage III or IV disease - No evidence of nodal disease below the clavicles - No distant hematogenous metastases (M0) PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - WBC > 3,500/mm³ - Platelet count > 100,000/mm³ - Creatinine = 2.0 mg/dL - Alkaline phosphatase < 2 times normal - AST < 2 times normal - Bilirubin = 2.0 mg/dL - Calcium normal - Not pregnant or nursing - Fertile patients must use effective contraception - Must not be a poor compliance risk for follow-up - No known severe hypersensitivity to gefitinib or any excipients of this drug - No evidence of clinically active interstitial lung disease - Patients with chronic, stable radiographic changes who are asymptomatic are eligible - No unstable or uncontrolled angina, clinically apparent jaundice, or active infection - No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ) unless disease free for = 5 years - No other severe, uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) PRIOR CONCURRENT THERAPY: - Recovered from prior oncologic or other major surgery - No prior definitive surgery, radiotherapy, chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for head and neck cancer - No investigational drugs within the past 30 days - No concurrent CYP3A4 inducers, including any of the following: - Phenytoin - Carbamazepine - Rifampin - Phenobarbital - Hypericum perforatum (St. John's wort) - Concurrent surgery allowed provided gefitinib is not administered 2 weeks before and 2 weeks after surgery - No concurrent aminoglycoside antibiotics |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
David Adelstein | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | Number of Participants With No Distant Metastatic Disease at 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. | 1 year | No |
Secondary | Number of Participants With No Local Disease at 1 Year | Number of Participants with No Local Disease at 1 Year. Local disease means that the cancer came back in the same site. | at 1 year after start of treatment | No |
Secondary | Number of Patients With Greater Than or Equal to Mild (Grade 1) Toxicity | Any toxicity greater than or equal to Grade 1= mild | at 1 year after start of treatment | Yes |
Secondary | Number of Patients With a Complete Response Defined as Complete Disappearance of All Clinically Detectable Tumor. | Complete response rate per RECIST Criteria (CTC V3) | 3 years | No |
Secondary | Number of Participants Who Completed 2 Years of Therapy | at 2 years after start of treatment | Yes |
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