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