A Phase II Study Of GW572016 In Squamous Cell Carcinoma Of The Head And Neck (SCCHN)

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