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 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT00003850
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven squamous cell carcinoma of the head and neck
* Recurrent disease OR metastatic disease at initial diagnosis or at recurrence
* Initial therapy of surgery and/or radiotherapy, induction chemotherapy, or concurrent chemotherapy and radiotherapy allowed
* No more than one prior regimen of chemotherapy or biologic therapy for metastatic disease
* Recurrence after adjuvant or induction chemotherapy may have received one additional course of chemotherapy or biologic therapy
PATIENT CHARACTERISTICS:
* Age: 18 and over
* Performance status: Zubrod 0-2
* Life expectancy: At least 3 months
* WBC at least 3000/mm3
* Platelet count at least 100,000/mm3
* Hematocrit at least 30%
* Bilirubin no greater than 1.5 times normal
* SGOT/SGPT no greater than 1.5 times normal
* Creatinine no greater than 1.5 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile women must use 2 methods of effective contraception, 1 barrier and 1 hormonal, beginning at least 4 weeks before study and continuing during and for 1 month after study
* Men must use effective barrier contraception during and for 1 month after study
* No grade 2 or greater peripheral neuropathy
* No serious infection or other concurrent illness requiring immediate therapy
* Must be able to take oral medications
* No medical or social factors that would interfere with compliance
PRIOR CONCURRENT THERAPY:
* Any number of courses of one regimen of chemotherapy allowed
* No concurrent cytotoxic chemotherapy
* No concurrent radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003850
Study Brief:
Protocol Section:
NCT00003850