Ph II Long Term/Low Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery, Radiation & or Chemo

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed squamous cell carcinoma of the head and neck, including 1 of the following primary tumor sites:
• •* Oral cavity
• •* Oropharynx
• •* Nasopharynx
• •* Hypopharynx
• •* Larynx
• •* Unknown primary
• •Any disease stage allowed
• •No evidence of active disease
• •Must have undergone curative surgical resection, radiotherapy, and/or chemotherapy at least 1 month, but no more than 4 years ago
• •PATIENT CHARACTERISTICS:
• •Performance status
• •Karnofsky 70-100%
• •Life expectancy
• •More than 3 months
• •Hematopoietic
• •White blood count (WBC) ≥ 3,000/mm\^3
• •Granulocyte count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hepatic
• •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• •Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≤ 2.5 times ULN
• •Alkaline phosphatase ≤ 2.5 times ULN
• •Hepatitis B and/or C negative
• •Renal
• •Creatinine clearance \> 50 mL/min
• •Cardiovascular
• •No myocardial infarction within the past 12 months
• •No uncontrolled congestive heart failure
• •No unstable or uncontrolled angina
• •Gastrointestinal
• •No lack of physical integrity of the upper gastrointestinal tract
• •Must be able to swallow tablet
• •No malabsorption syndrome
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •HIV negative
• •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer for which the patient is currently in complete remission
• •No history of uncontrolled seizures, central nervous system (CNS) disorders, or psychiatric disability that would preclude study compliance or giving informed consent
• •No ongoing postoperative fistula
• •No prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil
• •No other serious uncontrolled medical or surgical condition that would preclude study participation
• •PRIOR CONCURRENT THERAPY:
• •Chemotherapy
• •See Disease Characteristics
• •Prior oral fluoropyrimidine therapy allowed provided it was given in the adjuvant setting and completed ≥ 12 months ago
• •Radiotherapy
• •See Disease Characteristics
• •Surgery
• •See Disease Characteristics
• •More than 4 weeks since prior major surgery and recovered
• •No prior organ allografts
• •Other
• •More than 4 weeks since prior participation in any investigational drug study