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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT00468169
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or older
* Stage III and IV head and neck cancer
* Patients with squamous cell carcinoma of unknown primary and suspected origin in the head and neck area
* No prior chemotherapy or radiotherapy
* Prior surgical therapy of incisional or excisional biopsy and organ-sparing procedures only
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Normal organ and marrow function
Exclusion Criteria:
* Unequivocal demonstration of metastatic disease
* Known severe hypersensitivity to drugs used in the study
* Treatment with a non-approved or investigational drug within 30 days before Day 1
* Incomplete healing from previous surgery
* Pregnancy or breast feeding
* Uncontrolled intercurrent illness including
* Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF
* Acute hepatitis or known HIV
* Severe baseline neurologic deficits
* Prior therapy which specifically and directly targets the EGFR pathway
* Prior severe infusion reaction to a monoclonal antibody
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00468169
Study Brief:
Protocol Section:
NCT00468169