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 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT01185158
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed squamous cell carcinoma of the head and neck incurable by surgery or radiation
* Patients must have measurable disease, defined as at least on e lesion that can be accurately measured in the one dimension (longer diameter to be recorded) as greater then or equal to 20mm with conventional techniques or as greater than or equal to 10mm with computed tomograpy (CT) scan.
Therapeutic history that includes the Following:
* No prior EGFR-based therapy for recurrent disease
* No chemotherapy or irradiation with the 28-day period preceding entry to the study
* Eastern Cooperative Oncology Group (ECOG)performance Status 0-2 (kamofsky \>59%)
Patients must have normal organ and marrow function as defined below:
* leukocytes \>3,000ml
* absolute neutrophil count 1,500/ml
* platelets 100,000/ml
* total bilirubin within normal institutional limits
* AST(SGOT)ALT(SGPT) \<2.5 X institutional upper limits of normal
* Creatinine \<1.5
Exclusion Criteria:
* Other coexisting malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical in situ.
* Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, ketoconazole, erythromycin, clarithromycin, atorvastatin, cimetidine, ametidine, amitriptyline, imipramine, verpamil, tamoxifen, chlorpromazine, amiodorone, chloroquine, St. John's Wort
* Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
* Incomplete healing from previous oncologic or other major surgery Patients may not be receiving any other investigational agents
* History of allergic reactions attributed to compound of similar chemical or biologic composition to ZD 1839
* Uncontrolled intercurrent illness
* Pregnancy or breast feeding (women of child -bearing potential
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01185158
Study Brief:
Protocol Section:
NCT01185158