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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT00968435
Eligibility Criteria:
Inclusion Criteria:
* Stage III/IV HNSCC without distant metastasis. Patients with stage II squamous cell carcinoma of the hypopharynx will also be eligible
* Adequate renal function, with serum creatinine ≤ 1.5 mg/dL. Patients with serum creatinine \> 1.5 mg/dL may be eligible if calculated creatinine clearance \> or = to 55 ml/min by Cockcroft and Gault equation (or 24-hour urine collection).
* Age \> or = to 18 years.
* Karnofsky performance status \> or = to 70%
* Adequate bone marrow function: absolute neutrophil count \> or = to 1,500/ platelets \> or = to 100,000/ul, hemoglobin \> or = to 9 gm/dl
* Adequate hepatic function: Total bilirubin ≤ 1.5 X ULN (patients with Gilbert's syndrome as the cause of hyperbilirubinemia may be eligible if total bilirubin ≤ 2.5 X ULN), aspartate aminotransferase (AST) ≤ 2.5 X ULN, alanine aminotransferase (ALT) ≤ 2.5 X ULN, alkaline phosphatase ≤ 2.5 X ULN.
* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
* Patients must have ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Prior radiation therapy for HNSCC
* Prior treatment of HNSCC with bevacizumab or other agents specifically targeting VEGF
* Prior treatment of HNSCC with cetuximab or other agents specifically targeting EGFR
* Other active malignancy, other than indolent malignancies, which the investigator determines are unlikely to interfere with treatment or efficacy analysis. For example, patients with non-melanoma skin cancer, in situ carcinoma of the cervix, or prostate cancer within the no current biochemical (PSA) or radiologic evidence of disease may enroll.
* Patients with nasopharyngeal carcinoma
* Patients who will receive amifostine as part of the radiation treatment plan
* Patients with skin breakdown/ulceration (CTCAE version 3.0, grade 2 or higher).
* Patients with hearing loss requiring hearing aid or intervention (i.e. interfering in a clinically significant way with activities of daily living).
* Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living).
* Any prior documented history of transient ischemic attack (TIA) or cerebrovascular accident (CVA)
* History of unstable angina or myocardial infarction (MI) within the last year.
* Urine protein: creatinine (UPC) ratio \> or = to 1.0 at screening. A random urine sample is collected. Total protein (mg/dL) and spot creatinine (mg/dL) are ordered for this sample. The UPC ratio is calculated from the results of these tests.
* International normalized ratio (INR) \> 1.5 or activated partial thromboplastin time (aPTT) \> 1.5 X upper limits of normal (ULN)
* Current use of warfarin, current use of heparin or low-molecular weight heparin, chronic daily treatment with aspirin (\> 325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit platelet function.
* Patients with gross hemoptysis or hematemesis (defined as bright red blood of 1 teaspoon of more) within 28 days prior to Day 0 protocol treatment will be excluded from this trial. Patients with incidental blood mixed with phlegm are not excluded.
* Esophageal varices, non-healing ulcer, wound, or bone fracture are exclusion criteria. However, patients with skin breakdown overlying malignant neck lymphadenopathy may be eligible, at the discretion of the investigator.
* Anatomic lesion that increases the risk of serious hemorrhage, such as encasement or invasion of major blood vessels by primary tumor and/or by involved lymph nodes
* Blood pressure of \> 150/100 mmHg
* New York Heart Association (NYHA) Grade II or greater congestive heart failure.
* Clinically significant peripheral vascular disease
* History of bleeding diathesis or hemorrhagic disorder, or coagulopathy.
* Major surgical procedure or significant traumatic injury within 28 days prior to treatment with bevacizumab
* Core biopsy within 7 days prior to treatment with bevacizumab.
* Minor surgical procedures such as fine needle aspirations or placement of percutaneous gastrostomy tube (PEG) less than 7 days prior to treatment with bevacizumab
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior enrollment.
* Inability to comply with study and/or follow-up procedures
* Women who are pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00968435
Study Brief:
Protocol Section:
NCT00968435