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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT00405405
Eligibility Criteria:
Inclusion Criteria:
* Locally advanced Carcinoma (epithelial malignancy) of the head and neck. This may include non-squamous carcinomas (e.g. parotid, thyroid, melanoma) in which a large portion of mucosa of the oral cavity and/or laryngopharynx is expected to be irradiated.
* Stage IV disease (T4Nany or TanyN2-3).
* "Oligometastatic" disease is allowable if it is asymptomatic.
* Measurable disease is not required; patients who have had surgical resection are eligible provided that it is felt that the likelihood of cure with conventional postoperative therapy is \<40% and provided that there will be at least 28 days from the date of surgery to the start of study therapy.
* Performance status 0-1.
* Creatinine \< or = 1.5 mg/dl.
* ANC \> or = 1,800 cells/mm3.
* Platelets \> or = 150,000 cells/mm3.
* Hemoglobin \> or = 10 g/dl (transfusion is acceptable if needed).
* SGOT and/or SGPT \< or = 2.5 times the upper institutional limit of normal.
* INR \< or = 2.0.
* Age \> or = 18 (informed consent).
Exclusion Criteria:
* Current, recent (within 4 weeks of the Day 1, the first infusion of drug in this study) or planned participation in an experimental drug study other than this one.
* Poorly controlled blood pressure, defined as systolic bp \> 150 and/or diastolic bp \> 100 despite medication.
* Unstable angina.
* NY Heart Association (NYHA) Grade II or greater congestive heart failure.
* History of myocardial infarction or stroke within 6 months.
* Clinically significant peripheral vascular disease.
* Evidence of bleeding diathesis or coagulopathy.
* Presence of brain or spinal cord metastases.
* Major surgical procedure(s), open biopsy or significant traumatic injury within 28 days prior to Day 1 (1st day of study treatment) and/or anticipation of need for major surgical procedure during the course of the study.
* Urine protein: Creatinine ratio \> or = 1.0 at screening.\*
* Carotid artery exposure or other signs of impending carotid artery hemorrhage.
* History of abdominal fistula and/or gastrointestinal abdominal abscess within 6 months prior to enrollment.
* Serious, non-healing wound, ulcer, or bone fracture.
* Prior irradiation that would result in radiotherapy field "overlap."
* Requirement for high dose oral anticoagulation (i.e., goal INR \> 2.0). "Mini-dose" anticoagulation as may be used to assist in patency of central venous lines is acceptable. Subcutaneous Low-molecular weight heparin is allowable.
* No known allergies to any of the drug therapies being used in this protocol.
* No pregnancy, lactation or inability to use medically acceptable birth control if of childbearing potential.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00405405
Study Brief:
Protocol Section:
NCT00405405