Phase II Study of Oxaliplatin and Capecitabine in Advanced Head and Neck Malignancies

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed squamous cell cancer of
Head and Neck

- Patients must have metastatic or locally recurrent disease

- Patients must have disease not curable by surgery as estimated by one of the protocol
investigators, and should not be eligible for reradiation protocol or have failed
reradiation protocol.

- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as
>20 mm with conventional techniques or as >10 mm with spiral CT scan

- Age >18 years of age

- Life expectancy of greater than 12 weeks

- ECOG performance status 0, 1 or 2 (Karnofsky >50%; see Appendix B)

- Patients must have adequate bone marrow function as defined below:

- absolute neutrophil count > 1,500

- platelets > 100,000

- hemoglobin > 8 g/dl

- Patients must have adequate renal function as defined by a creatinine clearance >30
mL/min (measured or estimated by the Cockroft and Gault equation)

- Cockroft and Gault equation:

- Creatinine clearance for males =(140-age[yrs])(body wt[kg])/72(serum
creatinine[mg/dL])

- Creatinine clearance for females = 0.85 x male value

- Patients must have adequate liver function as defined below:

- total bilirubin 1.5x upper limit of normal

- albumin > 2.5 g/dl

- AST(SGOT) and ALT(SGPT) and Alkaline Phosphatase must be < 5 times upper limit
of normal

- Patients could have received 1 or 2 previous chemotherapy regimens prior to entering
the study. Patients must have recovered from acute toxicities from chemotherapy or
radiotherapy administered prior to entering this study. Alopecia may not be resolved
and peripheral neuropathy (grade 1) may be present.

- Patients with reproductive potential must use an adequate contraceptive method (e.g.,
abstinence, intrauterine device, oral contraceptives, barrier device with spermicide
or surgical sterilization) during treatment and for three months after completing
treatment.

- Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

- Prior unanticipated severe reaction to fluoropyrimidine therapy or known
hypersensitivity to 5-fluorouracil or oxaliplatin

- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to first
treatment in this study or those who have not recovered from adverse events due to
agents administered more than 4 weeks earlier

- Patients receiving any other investigational agent(s)

- Patients with symptomatic brain metastases or actively receiving any therapy for
brain metastasis (because of their poor prognosis and because they often develop
progressive neurologic dysfunction that would confound the evaluation of neurologic
and other adverse events)

- Active second malignancy in the last 5 years except for non-melanoma skin cancer or
carcinoma-in-situ

- Clinically significant cardiac disease (e.g. congestive heart failure, New York Heart
Association Class II or greater, symptomatic coronary artery disease and cardiac
arrhythmias) or myocardial infarction within the last 12 months.

- If patient is unable to swallow, xeloda may be crushed per hospital policy/procedure.
See attached Appendix G.

- Patients who have had an organ allograft.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnancy

- Known Hepatitis B , Hepatitis C, HIV

Inclusion of Minorities:

Members of all ethnic groups are eligible for this trial.