Clinical trial NCT00258310 (phase 2, status: completed)
Conditions: head and neck cancer
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: capecitabine
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
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