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A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer

Phase 1
18 Years
Not Enrolling
Head and Neck Cancer, Cancer of Parotid, Malignant Neoplasm of Thyroid, Melanoma, Stage IV Head and Neck Cancer

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Trial Information

A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer

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. Concurrent chemoradiotherapy is needed to optimize results, although
recent data suggest a benefit from induction therapy as well. Nonetheless, despite high
remission rates, most of these patients will suffer local-regional and/or distant recurrence
from their disease.

The proposed study will build upon the framework of chemoradiotherapy (induction plus
concurrent) via the addition of a double biologic therapy. Specifically, the combination of
bevacizumab and erlotinib will be used, as has been studied in other types of cancer.

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer

Outcome Description:

To determine if bevacizumab and erlotinib can be safely combined with chemoradiotherapy for advanced head and neck cancer.

Outcome Time Frame:

Day 36

Safety Issue:


Principal Investigator

Pramila Rani Anne, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

June 2010

Related Keywords:

  • Head and Neck Cancer
  • Cancer of Parotid
  • Malignant Neoplasm of Thyroid
  • Melanoma
  • Stage IV Head and Neck Cancer
  • Head and neck cancer
  • Parotid gland cancer
  • thyroid gland cancer
  • melanoma
  • Chemoradiotherapy
  • bevacizumab
  • erlotinib
  • Neoplasms
  • Thyroid Neoplasms
  • Head and Neck Neoplasms
  • Melanoma
  • Thyroid Diseases
  • Parotid Neoplasms



Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541