Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer

Phase II Trial Of Oxaliplatin With Docetaxel Followed By Epidermal Growth Factor Antibody (EGFR-AB) Cetuximab In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients to determine their effect on the control and reduction of tumor size

This is a non-randomized, open-label, phase II study to assess the effects of oxaliplatin and docetaxel followed by epidermal factor-antibody (EGFR-AB) cetuximab on patients with previously treated recurrent /metastatic squamous cell carcinoma of the head and neck. Head and neck tissue will also be tested to determine if the protein Epidermal Growth Factor Receptor is present in the cancer cells.

Inclusion Criteria:

• Histologically or cytologically confirmed recurrent SCCHN
• 18 years or older
• Tumor site accessible by biopsy
• Measurable disease
• Receiving no other therapy
• ECOG performance status 0-1
• Adequate bone marrow, renal function and hepatic function

Exclusion Criteria:

• Active infection or fever within 3 days of treatment
• Active CNS metastases
• Prior malignancy within 5 years
• Hypersensitivity to study drugs
• Chemotherapy within 30 days of treatment
• Concurrent investigational therapy within 30 days
• Radiotherapy of more than 25% of bone marrow
• Peripheral neuropathy of grade 2 or greater
• Pregnant or lactating patients
• History of allogeneic transplant
• Active or previously treated HIV or Hepatitis B or C
• Patients with a tracheostomy