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

PRIMARY OBJECTIVES:

I. Determine the overall response rate in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with lapatinib.

II. Determine the progression-free survival, time to progression, and overall survival of patients treated with this drug.

III. Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 cohorts according to prior epidermal growth factor receptor-targeted therapy (yes vs no).

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

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 40-88 patients (21-50 epidermal growth factor receptor [EGFR] inhibitor-naive patients [cohort A] and 19-38 EGFR inhibitor-pre-treated patients [cohort B]) will be accrued for this study within 4-12.6 months.

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