A Pilot Phase I Dose Escalation Study Of The EGFR Tyrosine Kinase Inhibitor Gefitinib (Iressa) Combined With Paclitaxel (Taxol) And External Beam Radiation Therapy In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck (SCCHN)

Date de début de l'étude : 1 mai 2004

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