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 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT00006361
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven epidermoid/squamous cell carcinoma of the oral cavity, lip, hypopharynx, oropharynx, nasopharynx, sinonasal tract, or larynx; undifferentiated carcinoma of the nasopharynx (WHO type III); sinonasal undifferentiated carcinoma; or squamous cell carcinoma of unknown primary or the skin with initial presentation in the head and neck region
* Advanced or recurrent disease that is incurable with surgery or radiotherapy
* No more than 2 prior cytotoxic chemotherapy regimens for recurrent, persistent, or metastatic disease
* Prior exposure to chemopreventive agents (e.g., tretinoin or other vitamin analogues) is not considered to be a prior cytotoxic chemotherapy exposure
* At least 1 measurable indicator lesion
* Bone metastases, elevated enzyme levels, or lesions on radionuclide scans are not acceptable as the sole parameters of measurable disease
* No history of brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 3,000/mm3
* Hemoglobin greater than 8 g/dL
* Platelet count greater than 100,000/mm3
* No history of coagulation disorder
Hepatic:
* Bilirubin normal
* SGOT less than 2.5 times upper limit of normal
* PT no greater than 14 seconds
* aPTT no greater than 40 seconds
Renal:
* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No uncompensated coronary artery disease
* No myocardial infarction or severe/unstable angina within the past 6 months
* No severe peripheral vascular disease associated with diabetes mellitus
* No deep venous or arterial thrombosis within the past 3 months
* No unstable cardiac rhythm
* No cerebrovascular accident within the past 6 months
Pulmonary:
* No pulmonary embolism within the past 3 months
Other:
* No history of allergic reaction to paclitaxel
* No other active malignancy except:
* Basal cell or squamous cell skin cancer
* Carcinoma in situ of the cervix
* Synchronous epidermoid/squamous cell carcinoma of the head and neck (oral cavity, lip, hypopharynx, oropharynx, nasopharynx, sinonasal tract, or larynx)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active bacterial infection requiring antibiotics
* No other concurrent medical condition that would increase risk
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006361
Study Brief:
Protocol Section:
NCT00006361