Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma
Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma
Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of
 patients with recurrent unresectable head and neck squamous cell carcinoma.
The investigator's approach is based on the following reasons:

 -  Low dose hyper-radiation sensitivity response will be significantly enhanced in
 Taxotere- induced G2/M cell cycle arrest.

 -  LDFRT will render enhanced bax activation mediated mode of cell death.

 -  Erbitux will arrest the cells in G1/G0 phase leading to p21-mediated mode of cell death.

 -  The toxicity profile is expected to be minimal.

 Based on the above mentioned reasons, we propose this novel schema of treatment in recurrent
 SCCHN.
Inclusion Criteria:

 1. Patients must have pathologically confirmed recurrence (reappearance of previously
 cleared) squamous cell cancer primary in the upper aerodigestive tract .Patients may
 have experienced more than one recurrence as long as the first recurrence occurred ≥ 6
 months following the end of the prior RT.

 2. The recurrence must have defined bi- or uni-dimensional measurements.

 3. Recurrence must be confined to the head and neck above the clavicles (loco-regional
 recurrence).

 4. The patient must not be a candidate for surgical resection.

 5. Patients must be at least 6 months from completion of prior chemotherapy and radiation
 therapy.

 6. Patients may have received prior chemotherapy as a component of their primary
 treatment, but not for recurrent disease.

 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

 8. Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum bilirubin ≤ 1.5 mg/dl,
 creatinine < 1.5 mg/dl within 3 weeks prior to registration.

 9. Liver Function Tests (LFTs) ≤ 2 x normal (serum glutamic oxaloacetic transaminase
 (SGOT)/serum glutamic-pyruvic transaminase (SGPT)/Alkaline Phosphatase). If > 2 x
 normal, liver ultrasound or CT is required to exclude metastases. If negative for
 metastases, patients are eligible.

 10. Patients must sign a study-specific informed consent form prior to study entry.

 Exclusion Criteria:

 1. Distant metastases outside of the head and neck.

 2. Primary disease in the nasopharynx or the salivary gland.

 3. Other concurrent invasive malignancies.

 4. Prior invasive malignancy unless disease free for at least two years (except prior in
 situ malignancies, e.g. cervix, breast, non-melanomatous skin cancer, etc. are
 permissible).

 5. Intercurrent medical illnesses which would impair patient tolerance to therapy or
 limit survival.

 6. Pre-existing grade ≥ 2 peripheral sensory neuropathy

 7. Pregnant and nursing women are excluded because of the potential teratogenic effects
 and potential unknown effects on nursing newborns.

 8. Prior history of sever hypersensitivity reaction to Docetaxol, Cetuximab or a drug
 with formulated with Polysorbate 80.