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 @ 4:35 AM
Ignite Modification Date:
2025-12-25 @ 4:35 AM
NCT ID:
NCT00084318
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma of the head and neck meeting the following criteria:
* Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding lip, nasopharynx, or sinuses)
* Gross total resection must be completed within 7 weeks of randomization, with pathology demonstrating one or more of the following risk factors:
* Histologic extracapsular nodal extension
* Histologic involvement of ≥ 2 regional lymph nodes
* Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual.
* Tonsillar cancer patients who undergo transoral excision of all gross tumor are eligible provided extracapsular nodal extension or involvement of ≥ 2 regional lymph nodes is histologically confirmed
* American Joint Committee on Cancer (AJCC) pathological stage III or IV
* No evidence of distant metastases
* No synchronous or concurrent head and neck primary tumors
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin \> 8.0 g/dL
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), and alkaline phosphatase meeting 1 of the following parameters:
* Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
* Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN
Renal
* Creatinine ≤ 1.5 mg/dL
Cardiovascular
* No unstable angina
* No uncontrolled hypertension
* No myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass surgery or percutaneous transluminal coronary angioplasty)
* No uncontrolled arrhythmia
* No congestive heart failure
* No more than 2 heart-related hospitalizations within the past year
* No other active cardiac disease
Pulmonary
* No more than 2 hospitalizations for chronic obstructive pulmonary disease within the past year
Neurologic
* No pre-existing peripheral neuropathy ≥ grade 2
* No uncontrolled seizure disorder
* No active neurological disease
Other
* No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior anti-epidermal growth factor receptor antibody therapy
Chemotherapy
* More than 3 years since prior cytotoxic chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior head and neck radiotherapy
Surgery
* See Disease Characteristics
Other
* No prior tyrosine kinase inhibitor therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00084318
Study Brief:
Protocol Section:
NCT00084318