Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT00083057
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00083057
Study Brief:
Protocol Section:
NCT00083057