Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck
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 lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed squamous cell (epidermoid) carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, or maxillary sinus Stage III or IV disease Distant metastases allowed provided both of the following are true: Metastases are confined to the head and neck region Metastases are encompassable in a radiotherapy field with curative intent Locally recurrent disease after primary surgery allowed Meets 1 of the following criteria: Unresectable disease Patient prefers chemoradiotherapy over surgery Measurable disease No brain metastases and/or carcinomatous meningitis PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic WBC ≥ 3,000/mm^3 Hemoglobin > 10 g/dL Platelet count > 100,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Hepatic Bilirubin < 2.0 times upper limit of normal (ULN) AST/ALT ≤ 2.5 times ULN Renal Creatinine < 1.5 times ULN OR Creatinine clearance ≥ 60 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Pulmonary No clinically active interstitial lung disease Chronic, stable, asymptomatic radiographic changes allowed Other No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs or Cremophor^® EL No AIDS or primary immunodeficiencies No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix Probability of recurrence of the prior malignancy < 5% No other concurrent uncontrolled illness No ongoing or active serious infection No psychiatric illness or situation that would preclude study compliance or giving informed consent Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for cancer No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy No prior therapeutic radiotherapy to the head and neck region No prior radiotherapy for cancer Surgery See Disease Characteristics At least 4 weeks since prior major surgery and recovered Other No prior gefitinib or other epidermal growth factor receptor inhibitors More than 4 weeks since prior non-approved or investigational agents No concurrent administration of any of the following: Phenytoin Carbamazepine Barbiturates Rifampin Hypericum perforatum (St. John's wort) Oxcarbazepine Rifapentine Amifostine Modafinil Other CYP3A4 enzyme inducers Other anticancer agents or investigational drugs Combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
- NCI - Metabolism Branch;MET