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

Primary Objective:To establish the response rate using RECIST 1 criteria to weekly TPC in patients with metastatic or relapsed squamous cell carcinoma of the head and neck Secondary Objective: To establish the safety profile, progression free and overall survival of weekly TPC in this patient population.

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