Clinical Trial Details

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Study ID 06C.46
Investigator
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
Melanoma
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
    Thomas Jefferson University
    Philadelphia, Pennsylvania, 19107
    Contact N/A

    Information objtained from ClinicalTrials.gov, on 10/30/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT00405405


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