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:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT00352105
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00352105
Study Brief:
Protocol Section:
NCT00352105