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).