Status:
COMPLETED
Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Head and Neck Cancer
Parotid Gland Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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
Detailed Description
Locally advanced non-operative, Stage IV head and neck cancer has at best a guarded prognosis. Improvements in outcome have been achieved via the combination of chemotherapy and radiotherapy. Concurre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00405405
Start Date
December 1 2006
End Date
June 1 2010
Last Update
May 6 2025
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107