Pramila Rani Anne, MD, Thomas Jefferson University
Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer
Head and Neck Cancer
Cancer of Parotid
Malignant Neoplasm of Thyroid
Stage IV Head and Neck Cancer
To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab
when used with chemotherapy and radiation therapy in advanced head and neck cancer
Ages Eligible: 18 Years
Accepts Healthy Volunteers:
- 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
- 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).
- 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
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
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Information objtained from ClinicalTrials.gov, on
4/23/2014. For additional information about
this and other clinical trials,
Please refer to this study by its ClinicalTrials.gov identifier: