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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT00004094
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed squamous cell or poorly differentiated carcinomas, or lymphoepithelioma of the head and neck
* Stage III carcinoma of the base of the tongue or hypopharynx
* Stage IV carcinoma of the oral cavity, pharynx (including nasopharynx, oropharynx, and hypopharynx), or larynx
* No distant metastasis
* Measurable disease desirable
* Clinically disease free after prior surgery allowed
PATIENT CHARACTERISTICS:
Age:
* 15 to 80
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 2 times ULN
* Alkaline phosphatase no greater than 2 times ULN
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* No clinically significant cardiomyopathy or congestive heart failure
Pulmonary:
* No clinically significant pulmonary dysfunction
Other:
* No severe baseline neurologic deficits
* No uncontrolled active infection other than that not curable without treatment of cancer
* No sensitivity to Cremophor EL
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy
Surgery:
* See Disease Characteristics
* Incisional or excisional biopsy and organ sparing procedures (e.g., debulking of airway compromising tumors or neck dissection) in patients with an existing primary tumor allowed
* No more than 3 months since prior nonbiopsy procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
80 Years
Study:
NCT00004094
Study Brief:
Protocol Section:
NCT00004094