RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It may also stop the growth of tumor cells by stopping blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with recurrent or metastatic head and neck cancer.

OBJECTIVES:

Primary

• Determine the response rate (confirmed, complete and partial responses) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with sorafenib.
• Determine the median progression-free survival and median overall survival of patients treated with this drug.

Secondary

• Determine the qualitative and quantitative toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3.3-8 months.

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the head and neck meeting 1 of the following criteria:

  • Metastatic at diagnosis
  • Persistent, recurrent, or metastatic disease after definitive surgery and/or radiotherapy
  • Relapsed disease after prior induction or adjuvant therapy
• Not amenable to salvage surgical resection
• No newly diagnosed nonmetastatic disease

• Measurable disease

  • If only site of measurable disease is within a prior radiotherapy port, then clearly progressive disease must be demonstrated
• No prior or concurrent CNS metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count > 1,500/mm^3
• Platelet count > 100,000/mm^3
• No bleeding diathesis

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2 times ULN
• SGOT or SGPT ≤ 2 times ULN

Renal

• Creatinine < 2 times ULN

Cardiovascular

• No significant history of cardiac disease
• No uncontrolled hypertension
• No congestive heart failure
• No myocardial infarction within the past 6 months
• No unstable angina
• No cardiac ventricular arrhythmias requiring medication

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• Able to take oral medication without crushing, dissolving, or chewing tablets
• No active infection requiring systemic therapy
• No psychological, familial, sociological, or geographical condition that would preclude study participation or compliance
• 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 adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent immunotherapy, biologic therapy, or gene therapy for the malignancy

Chemotherapy

• No prior chemotherapy for recurrent disease or newly diagnosed metastatic disease

• At least 6 months since prior induction or adjuvant chemotherapy

  • No more than 1 prior induction or adjuvant regimen
• No concurrent chemotherapy for the malignancy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and recovered
• No concurrent radiotherapy for the malignancy

Surgery

• See Disease Characteristics
• At least 4 weeks since prior surgery and recovered

Other

• No concurrent therapeutic anticoagulation
• No other concurrent therapy for the malignancy