Lapatinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

Inclusion Criteria:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck

  • Recurrent and/or metastatic disease

• Measurable disease

  • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• No more than 2 prior treatment regimens for recurrent or metastatic disease

  • Prior chemotherapy as part of initial curative intent therapy (e.g., neoadjuvant, adjuvant, or concurrent chemotherapy) is allowed and does not count as prior therapy for recurrent or metastatic disease
• No known brain metastases
• Performance status - ECOG 0-2
• Performance status - Karnofsky 60-100%
• More than 3 months
• Bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal
• Creatinine normal
• Creatinine clearance > 60 mL/min
• Cardiac ejection fraction normal by echocardiogram or MUGA
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Able to swallow and retain oral or feeding tube-administered medication
• No malabsorption syndrome
• No requirement for IV alimentation
• No uncontrolled inflammatory gastrointestinal disease (e.g., Crohn's disease or ulcerative colitis)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of allergic reaction attributed to compounds of similar chemical or biologic composition to lapatinib
• No other uncontrolled illness
• No active or ongoing infection
• No psychiatric illness or social situation that would preclude study compliance
• Prior cetuximab allowed
• See Disease Characteristics
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• No prior cumulative anthracycline therapy ≥ 450 mg/m^2 of doxorubicin or equivalent
• More than 4 weeks since prior radiotherapy
• No prior surgical procedure affecting absorption
• Recovered from prior therapy
• Other prior epidermal growth factor receptor inhibitors (e.g., gefitinib or erlotinib) allowed
• Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased vigilance in monitoring INR
• No concurrent CYP3A4 inhibitors or inducers
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents
• No other concurrent anticancer therapy