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 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT00720304
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed locally advanced squamous cell carcinoma of the head and neck
* Stage III or IV disease
* No distant metastatic disease
* Measurable disease (according to RECIST)
* No salivary gland and paranasal sinus squamous cell carcinoma
* No known brain metastases or direct cerebral invasion by tumor
* Intracranial extension (without cerebral involvement) may be allowed
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Life expectancy \> 12 weeks
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥10 g/dL
* Total bilirubin normal
* Alkaline phosphatase AND AST and ALT meeting the following criteria:
* Alkaline phosphatase normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN AND AST and ALT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 5 times ULN AND AST and ALT normal
* Creatinine normal OR creatinine clearance ≥ 60 mL/min
* No clinically significant heart disease including any of the following:
* NYHA class III or IV heart disease
* Significant arrhythmias requiring medication
* Symptomatic coronary artery disease
* Myocardial infarction within the previous six months
* Second- or third-degree heart block or bundle-branch block
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after completion of study therapy
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib hydrochloride or docetaxel, including other drugs formulated with polysorbate 80
* No pre-existing peripheral neuropathy ≥ grade 2
* No uncontrolled concurrent illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness/social situations that would preclude compliance with study requirements
* No HIV positivity
* No other prior malignancy except for any of the following:
* Squamous cell or basal cell carcinoma of the skin
* Carcinoma in situ of the cervix
* Cancer that was treated more than 5 years ago and the patient has remained disease-free
* Not poorly compliant
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy, radiotherapy, or investigational antitumor drug
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00720304
Study Brief:
Protocol Section:
NCT00720304