Docetaxel, Cisplatin, and Cetuximab in Treating Patients with Metastatic or Relapsed Head and Neck Cancer

Inclusion Criteria

• Squamous cell carcinoma of head and neck sites, including all pharynx, larynx, oral cavity, skin and para-nasal sinus sites; patients with a diagnosis of nasopharyngeal carcinoma, or squamous cell carcinoma (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
• Eastern Cooperative Oncology Group (ECOG) performance status < 3 at enrollment is required
• Absolute neutrophil count >= 1500/mm^3
• Platelet count >= 100 K/mm^3
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limit of normal (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 total (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
• Peripheral neuropathy < grade 2
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• No prior palliative chemotherapy
• Patients with active infections including known human immunodeficiency virus (HIV) are not eligible; HIV positive patients on highly active anti-retroviral therapy (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
• 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 known brain metastasis are eligible only if by central nervous system (CNS) imaging there is no evidence of CNS progression at least 30 days following definitive CNS treatment (resection or radiation)