Docetaxel and Capecitabine for First Line Treatment of Metastatic Squamous Cell Carcinoma of the Head & Neck

Inclusion Criteria:

• Histologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck.
• Recurrent/metastatic disease not amenable to surgery or salvage chemoradiation.
• Unidimensional measurable disease according to the RECIST
• In-field recurrence, within a prior radiation field only, distant metastatic disease
• Both in-field and metastatic sites of disease will require evaluation by a Radiation Oncologist to consider local radiation therapy first and will be eligible for possible enrollment one month after completion of the radiation therapy.
• Negative pregnancy test
• Patients may have received prior chemotherapy as part of chemoradiation or induction chemotherapy for initial treatment of disease confined to the head and neck region - Patients must have fully recovered from any prior radiation therapy

Exclusion Criteria:

• Patients who have relapsed < 6 months after completing a combined modality curative treatment that included a fluoropyrimidine or taxanes
• No brain metastases
• No major neurological disease, including stroke
• No prior chemotherapy regimen for recurrent/metastatic disease
• No prior history of capecitabine usage
• No prior history of docetaxel usage except in the induction setting for head and neck cancer which has been completed for greater than 6 months prior to beginning protocol therapy
• No past hypersensitivity to taxanes or 5 FU
• No hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
• No current use of warfarin
• Patients must not be receiving ketoconazole, midazolam, erythromycin, orphenadrine, troleandomycin, cyclosporine or antiepileptics
• Patients must not be treated with any of the following on protocol therapy or within 28 days prior to beginning protocol therapy: sorivudine, brivudine, cimetidine, allopurinol
• Patients must have fully recovered from any prior surgery
• No known HIV seropositivity.
• No serious uncontrolled medical condition, uncontrolled peptic ulcer disease or malabsorption syndrome
• No peripheral neuropathy > grade 1
• Patients with a percutaneous gastrostomy (PEG) must be able take medications by tube.
• No daily consumption of alcohol
• No active infection
• No prior history of malignancy in the last 5 years, excluding in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin or Gleason Grade < VII organ confined prostate cancer.
• No current breastfeeding