Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally Advanced Head and Neck Cancer
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx
Eligibility Criteria
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
Sites / Locations
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Concurrent Chemotherapy and ZD1839