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 @ 5:02 PM
Ignite Modification Date:
2025-12-24 @ 5:02 PM
NCT ID:
NCT00057850
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma of the head and neck considered incurable by surgery or radiotherapy
* No nasopharyngeal disease as primary site
* Extensive, local-regional or distant metastatic disease
* Newly diagnosed OR
* Recurrent disease after initial treatment with surgery or radiotherapy (including neoadjuvant chemotherapy or concurrent chemoradiotherapy)
* Measurable disease
* If only site of measurable disease is in a previously irradiated area, disease progression after radiotherapy must be documented
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Hematopoietic
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 2.0 mg/dL
* Transaminases no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver involvement)
Renal
* Creatinine no greater than 1.5 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No evidence of active infection
* No other malignancy within the past 2 years except curatively treated stage 0 or I cancer
PRIOR CONCURRENT THERAPY:
Chemotherapy
* No prior chemotherapy for recurrent disease
Radiotherapy
* At least 6 months since prior radiotherapy and recovered
Surgery
* Recovered from prior surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00057850
Study Brief:
Protocol Section:
NCT00057850