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 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT00281866
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma of the head and neck
* Metastatic and/or locally recurrent disease
* No undifferentiated and nonkeratinizing carcinomas, including lymphoepitheliomas of all locations, as well as tumors of the parotid gland
* WHO Type I squamous cell carcinoma of the nasopharynx are allowed
* Incurable with surgery or radiotherapy
* Measurable disease, defined as ≥ 1 target lesion ≥ 20 mm OR ≥ 10 mm on spiral CT scan
* If the only site of measurable disease is in a previously irradiated area, the patient must have documented progressive disease by tomography or biopsy-proven residual carcinoma
* No symptomatic brain metastases that are not stable, are not adequately controlled with fixed-dose oral steroids, are potentially life-threatening, or have required radiotherapy within the last 14 days
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Predicted life expectancy ≥ 12 weeks
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and/or ALT ≤ 2.5 times ULN
* Creatinine ≤ 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must practice effective contraceptive measures
* No other prior malignancy within the past 3 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
* No active or uncontrolled infection or other serious illnesses or medical conditions
* No history of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No more than two prior chemotherapy regimens for locally recurrent and/or metastatic disease
* Prior induction chemotherapy or chemoradiotherapy with curative intent for local disease allowed provided patient has received no more than two prior chemotherapy regimens for recurrent disease
* Prior therapy must have been completed a minimum of 14 days prior to study AND patient has recovered
* No prior molecular-directed therapies, such as tyrosine kinase inhibitors and/or monoclonal antibodies
* At least 14 days must have elapsed between the end of radiotherapy and study registration and recovered
* At least 14 days since prior surgery AND wound healing has occurred
* At least 7 days since prior herbal extracts and tinctures with CYP3A inhibitory activity, including any of the following:
* Hydrastis canadensis (goldenseal)
* Uncaria tomentosa (cat's claw)
* Echinacea angustifolia roots
* Trifolium pratense (wild cherry)
* Matricaria chamomilla (chamomile)
* Glycyrrhiza glabra (licorice)
* Dillapiol
* Naringenin
* No other concurrent anticancer therapy or other investigational agents
* No concurrent administration of any of the following:
* Phenytoin
* Carbamazepine
* Rifampicin
* Barbiturates
* Hypericum perforatum (St. John's wort)
* CYP3A inhibitors (e.g., itraconazole)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00281866
Study Brief:
Protocol Section:
NCT00281866