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

OBJECTIVES:

Primary

• Determine the objective response rate in patients with chemotherapy naïve relapsed or metastatic head and neck cancer treated with oxaliplatin and capecitabine.

Secondary

• Evaluate the safety and toxicity of this regimen in these patients.
• Determine the one-year survival and overall survival of these patients.

OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 2-15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

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