Oxaliplatin and Capecitabine in Treating Patients With Relapsed or Metastatic Head and Neck Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed head and neck cancer
• * Relapsed or metastatic disease
• Measurable disease
• No CNS metastases (unless CNS metastases have been stable for \> 3 months)
• No clinically significant pericardial effusion
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-2
• Life expectancy \> 3 months
• Absolute granulocyte count \> 1,500/mm³
• Platelet count \> 100,000/mm³
• Bilirubin \< 2.0 times upper limit of normal (ULN)
• AST or ALT \< 2.5 times ULN
• Alkaline phosphatase \< 2.5 times ULN (5 times ULN if liver metastases are present or 10 times ULN if bone disease is present)
• Creatinine clearance ≥ 30 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 30 days after completion of study treatment
• No clinically serious, uncontrolled cardiovascular disease
• No New York Heart Association class III-IV heart disease
• No myocardial infarction within the past 6 months
• No congestive heart failure
• No unstable angina
• No arrhythmia
• No concurrent serious, uncontrolled infections
• No other cancer requiring treatment within the past 5 years, except cured nonmelanoma skin cancer or treated in situ cervical cancer
• No loss of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
• No history of persistent neurosensory disorder including, but not limited to, peripheral neuropathy
• No history of uncontrolled seizures or CNS disorders
• No history of psychiatric disability or other serious uncontrolled medical condition that would preclude study compliance
• No history of clinically significant interstitial lung disease and/or pulmonary fibrosis
• No prior hypersensitivity or unanticipated severe reaction to fluoropyrimidine therapy, fluorouracil, or platinum-based compounds
• PRIOR CONCURRENT THERAPY:
• No prior chemotherapy for metastatic or relapsed disease
• More than 4 weeks since prior major surgery and recovered
• More than 4 weeks since prior participation in any investigational drug study
• At least 6 months since prior adjuvant fluoropyrimidine therapy
• * No other prior fluoropyrimidines
• At least 6 months since prior adjuvant platinum-based therapy
• * No other prior platinum-based therapy
• No concurrent radiotherapy to the head and neck
• No other concurrent chemotherapy