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 (SCC) of head and neck (SCCHN), 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.
* If prior chemoradiation, radiation, and/or surgery in the potentially curative setting, \> 3 months has elapsed since the end of the potentially curative treatment ended
* If history of other malignancies treated curatively \> 1 year prior to enrollment, no evidence of relapse at the time of enrollment
* If brain metastasis, central nervous system (CNS) imaging documents no evidence of CNS progression at least 30 days following definitive CNS treatment (resection or radiation)
* ≥ 16 years old
* Eastern cooperative oncology group (ECOG) Performance Status \< 3
* Laboratory value requirements at enrollment:
* Absolute neutrophil count \> 1500/mm³
* Platelet count \> 100,000/mm³
* Hemoglobin \> 8 g/dL
* Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \< 2.5 x upper limit of normal (ULN) unless liver metastases documented. If so, AST and ALT \< 5 x ULN required.
* Total bilirubin \< 1.5 x ULN, EXCEPT if Gilbert's syndrome is present. If so, total bilirubin \< 2.5 x ULN
* Serum Creatinine \< 1.5 mg/dL OR an estimated creatinine clearance from 24 hour urine collection \> 50 mL/min
* Peripheral neuropathy \< grade 2
* Hearing loss in best ear \< grade 2 per Chang criteria if audiogram performed. 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

* Prior palliative chemotherapy
* Active infections including HIV (EXCEPTION: HIV-positive patients on HAART with undetectable blood HIV levels, or with history or serological evidence of exposure to Hepatitis B without active infection are eligible)
* Prior grade 3 allergic or infusion reactions to docetaxel, cisplatin or cetuximab (EXCEPTION: a history of infusion reactions that were well-tolerated, at physician's discretion)
* Pregnant and/or lactating