This is an open-label, non-randomized, two arm, Phase I research study of superselective
intraarterial Cetuximab (Erbitux) with or without radiation therapy for treatment of
recurrent unresectable squamous cell carcinoma of the head and neck (HNSCC).
1. Male or female patients of ≥18 years of age.
2. Patients with a documented diagnosis of recurrent head and neck squamous cell cancer
(squamous cell carcinoma, including nasopharyngeal cancer, or adenoid cystic
Patients must have at least one confirmed and evaluable tumor site.* The recurrence
must have bidimensional measurements by clinical examination or CT/MRI/PET scan. A
confirmed recurrence site may also be biopsy-proven
3. Tumor Recurrence which is surgically unresectable
4. Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level
of 0-2) (see Appendix Performance Status Evaluation) and an expected survival of ≥
5. Patients must have adequate hematologic reserve with WBC≥3000/mm3, absolute
neutrophils ≥1500/mm3 and platelets ≥100,000/ mm3. Patients who are on Coumadin must
have a platelet count of ≥150,000/ mm3
6. Pre-enrollment chemistry parameters must show: bilirubin<1.5X the institutional upper
limit of normal (IUNL); AST or ALT<2.5X IUNL and creatinine<1.5X IUNL.
7. Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL.
8. Patients must agree to use a medically effective method of contraception during and
for a period of three months after the treatment period. A pregnancy test will be
performed on each premenopausal female of childbearing potential immediately prior to
entry into the research study.
9. Patients must be able to understand and give written informed consent. Informed
consent must be obtained at the time of patient screening.
10. Patients who refuse surgery.
1. Women who are pregnant or lactating.
2. Women of childbearing potential and fertile men will be informed as to the potential
risk of procreation while participating in this research trial and will be advised
that they must use effective contraception during and for a period of three months
after the treatment period.
3. Patients with significant intercurrent medical or psychiatric conditions that would
place them at increased risk or affect their ability to receive or comply with
treatment or post-treatment clinical monitoring.
4. Pre-existing cardiac or respiratory disorders
5. Unrelated malignancy within 3 years
6. History of hypersensitivity reactions to other EGFR inhibitors
7. Metastatic disease
8. Less than 6 months from prior Radiation Therapy (Arm 1)
9. Previous exposure to Cetuximab