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