Clinical Trial Details

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Study ID 06C.46
Pramila Rani Anne, MD,   Thomas Jefferson University
Title Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer
Conditions Head and Neck Cancer
Cancer of Parotid
Malignant Neoplasm of Thyroid
Stage IV Head and Neck Cancer
Interventions Drug: Cisplatin
Drug: Docetaxel
Drug: Bevacizumab
Drug: Erlotinib
Radiation: Radiotherapy
Phase Phase 1
Purpose 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
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Both
Accepts Healthy Volunteers:  No
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.
  • Study Location N/A
    Contact N/A

    Information obtained from, on 7/31/2015. For additional information about this and other clinical trials, visit
    Please refer to this study by its identifier: NCT00405405

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