A Single Arm Phase II Trial of Docetaxel and Capecitabine for the First Line Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN): Hoosier Oncology Group HN02-40

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