Ph II Long Term/Low Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery, Radiation & or Chemo
Condition: Head and Neck Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: capecitabine; Surgery, chemotherapy and/or radiotherapy
Intervention description: Capecitabine 1000mg/day for one year; Surgery, chemotherapy and/or radiotherapy
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I squamous cell carcinoma of the hypopharynx; stage I squamous cell carcinoma of the larynx; stage I squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the nasopharynx; stage I squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the nasopharynx; stage II squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the oropharynx

Summary:

      RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Giving capecitabine after surgery, radiation therapy, and/or chemotherapy may kill any
      remaining tumor cells.

      PURPOSE: This phase II trial is studying how well capecitabine works in treating patients who
      have undergone previous surgery, radiation therapy, and/or chemotherapy for head and neck
      cancer.
    

Eligibility 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