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

OBJECTIVES:

Primary

• Determine the feasibility of adjuvant low-dose capecitabine in patients with squamous cell carcinoma of the head and neck who have undergone prior curative surgery, radiotherapy, and/or chemotherapy.

Secondary

• Determine the time to recurrence, local-regional control, and survival rate in patients treated with this drug.
• Determine the incidence of second primary tumors in patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive oral capecitabine once daily for 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.

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