A Study of a New Combination and Schedule of Chemotherapy Drugs for the Treatment of Head and Neck Cancer

Inclusion Criteria

• Patients must have documented advanced, locally recurrent, or metastatic head and neck carcinoma, which is untreatable by surgical resection or radiation therapy.
• Prior chemotherapy for advanced/metastatic disease is allowed (1 regimen only).
• Patients must be taxane-naïve (no prior docetaxel or paclitaxel).
• Patients who have received chemoradiation as a primary therapy for advanced head and neck cancer are eligible.
• Patients must have measurable or evaluable disease. Pre-study imaging for disease assessment must be done within 28 days of registration.
• Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy.
• Aged 18 years or older
• Performance status of 0-2 by Zubrod criteria.
• Life expectancy of at least 12 weeks.
• Hematologic: absolute neutrophil count (ANC) equal to or > 1,500/mm3; hemoglobin equal to or > 8.0 g/dl; platelets equal to or > 100,000/mm3.
• Total bilirubin must be within normal institutional limits (WNL).
• Transaminases (AST/SGOT and ALT/SGPT) may be up to 2.5 X the institutional upper limit of normal (ULN) if alkaline phosphatase is less than ULN, or alkaline phosphatase may be up to 4 X ULN if transaminases are less than ULN.
• A calculated creatinine clearance of > 50 ml/min
• Women of childbearing potential must have a negative pregnancy test at baseline, prior to receiving any study drug. (Pregnant or lactating patients are excluded.)
• Patients of reproductive potential must practice effective contraception while on study and for at least six months after receiving the last dose of study drug.
• All patients must sign an informed consent prior to enrollment.
• No prior history of malignancy, except for adequately treated skin cancer or in situ cervical carcinoma or any other cancer in complete remission for at least two years.

Exclusion Criteria

• Patients with congestive heart failure, second or third degree heart block or recent myocardial infarction within 12 months from registration are not eligible.
• Peripheral neuropathy equal to or greater than grade 2.
• Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
• Use of standard chemotherapy or investigational agents for treatment of head and neck cancer within 28 days of 1st dose of study drug.
• Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen.
• Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
• Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test (PPT) at baseline, or sexually active females not using a reliable contraceptive method while on study and for at least six months after chemotherapy. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.)
• Sexually active patients not using a reliable contraceptive method while on study and for at least six months after chemotherapy.
• Patients with malabsorption syndromes will be excluded. Administration of capecitabine through feeding tubes is permitted.
• Serious concurrent infections.
• Any other serious uncontrolled medical or surgical conditions that the investigator feels might compromise study participation.