AP5346 or Oxaliplatin in Treating Patients With Metastatic and/or Unresectable Recurrent Head and Neck Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary squamous cell carcinoma of the head and neck, including the oral cavity, oropharynx, hypopharynx, larynx, or nasopharynx

  • Metastatic and/or unresectable locally recurrent disease for which no curative treatment is available

    • Patients must not be candidates for surgical resection or radiotherapy with curative intent
    • Histological documentation of relapse required, especially for locoregional recurrence or recurrence in a previously irradiated field

• Tumor(s) must be amenable to minimally invasive biopsy during the first course of treatment

  • Must have evidence of progression or appearance of a new lesion after completion of radiotherapy, if biopsy site is in a previously irradiated field

PATIENT CHARACTERISTICS:

• WHO performance status 0-2
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Absolute neutrophil count ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL
• Bilirubin < 1.5 times upper level of normal (ULN)
• Alkaline phosphatase (AP) ≤ 5 times normal (unless elevation is due to bone disease or bone metastasis in the absence of liver disease)

• AST and ALT ≤ 3 times ULN

  • AST and ALT > 3 times ULN allowed provided AP ≤ 3 times ULN
• Blood urea < 1.5 times ULN
• Creatinine < 1.5 times ULN OR creatinine clearance > 60 mL/min OR creatinine clearance by 24-hour urine collection normal
• Calcium normal
• No history of hypersensitivity reactions of any kind to cisplatin or carboplatin
• No other serious medical condition or psychiatric illness that would preclude the patient's ability to give informed consent or receive study treatment
• No symptomatic peripheral neuropathy ≥ grade 2
• No need for IV alimentation

• No other serious illness or medical condition, including, but not limited to, the following:

  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris or cardiac arrhythmia
  • Significant neurologic or psychiatric disorders, including dementia or uncontrolled seizures
  • Hypophosphatemia

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 4 weeks since prior and no other concurrent anticancer treatment (i.e., chemotherapy, chemoradiotherapy, or radiotherapy)
• At least 4 weeks since prior biologic therapy

• No prior oxaliplatin

  • Prior cisplatin or carboplatin allowed
• No concurrent anticoagulants other than cardioprotective doses of aspirin, cyclooxygenase 1-inhibitory nonspecific anti-inflammatory drugs, or prophylactic low-dose heparin
• Concurrent bisphosphonates for hypercalcemia allowed provided the drug was initiated ≥ 3 months prior to study entry