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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT00660218
Eligibility Criteria:
Inclusion Criteria:
* Patients with histological proof (from the primary lesion and/or cervical lymph node) of squamous carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, or unknown primary.
* Patients should have stage III or IV disease
* Patients must have ECOG Performance Status of 0-1
* Patients must be \>/= 18 years of age
* Patients must have measurable disease
* Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of \>/= 1500 cells/mm3, platelet count of \>/= 100,000 cells/ mm3; adequate hepatic function with bilirubin \</= 1.5mg/dl, AST and ALT \</= 2x the upper limit of normal; serum creatinine \</= 1.5mg/dl, creatinine clearance \>/= 50 ml/min and INR 0.8 - 1.2
* Patients must sign a study specific informed consent form prior to study entry
* Final 20 subjects must be HPV negative
Exclusion Criteria:
* Histology other than squamous cell carcinoma
* Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations for phase II study subjects
* History of malignancy other than non-melanoma skin cancer
* Prior chemotherapy or anticancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region except for radioactive iodine therapy
* Prior history of allergy or hypersensitivity to cetuximab or paclitaxel
* Weight loss \> 10% in the past three months
* Patients with uncontrolled intercurrent disease
* Patients with currently active malignancy
* Pregnant or lactating women
* Female patients of childbearing potential who are unwilling to practice adequate contraception during study treatment and for two months after the last administration of study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00660218
Study Brief:
Protocol Section:
NCT00660218