Weekly Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Inclusion Criteria:

- Squamous cell carcinoma of head and neck sites, including all pharynx, larynx, oral
cavity, skin and para-nasal sinus sites. Patients with SCC of unknown primary
presenting in the neck clinically compatible with head and neck mucosal primary sites
are eligible.

- Patients who have received prior chemoradiation, radiation, and/ or surgery in the
potentially curative setting are eligible as long as 3 months has elapsed since the
end of the potentially curative treatment ended.

- Patients must be greater than 16 years old.

- ECOG Performance Status < 3 at enrollment is required.

- Laboratory value requirements at enrollment:

- Absolute neutrophil count > 1500/mm3

- Platelet count >100K/mm3

- Hemoglobin > 8 g/dL

- AST and ALT < 2.5 x ULN unless liver metastases documented. In this latter case,
AST and ALT < 5 x ULN required.

- Total Bilirubin < 1.5 x ULN unless the patient has Gilbert's syndrome, in which
case T. Bilirubin < 2.5 x ULN required

- Serum Creatinine < 1.5 mg/dL OR an estimated creatinine clearance from 24 hour
urine collection > 50 ml/min

- Clinical requirements at enrollment:

- Peripheral neuropathy < grade 2

- Hearing loss in best ear < grade 2 per Chang criteria if audiogram performed. *24
Formal audiology is not required in patients with no clinical evidence of hearing
loss at baseline.

- Ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria:

- No prior palliative chemotherapy

- Patients with active infections including HIV are not eligible. HIV positive patients
on HAART with undetectable blood HIV levels are eligible. Patients with a history or
serological evidence of exposure to Hepatitis B without active infection are eligible
for this study.

- Patients with prior grade 3 allergic or infusion reactions to docetaxel, cisplatin or
cetuximab are not eligible. A history of well tolerated infusion reactions is NOT an
exclusion.

- Pregnant women and/or nursing patients will be excluded from the study because of
potential harm to the fetus or nursing infant.

- Because the primary endpoint of this study is response rate and not survival, patients
with a history of other malignancies treated curatively greater than one year prior to
enrollment and without evidence of relapse at the time of enrollment are eligible.

- Patients with brain metastasis are eligible only if by CNS imaging there is no
evidence of CNS progression at least 30 days following definitive CNS treatment
(resection or radiation).