Inclusion Criteria:
- At least one measurable lesion by RECIST criteria
- A tumor lesion that can be readily biopsied using a core needle via clinical exam,
ultrasound, CT, or fluoroscopic-guidance
- Over the age of 18 years and able to provide informed consent
- Patients must have progressed after standard therapy for metastatic/ recurrent
disease including 5-FU containing regimens for patients with colorectal cancer, and
platinum-containing regimens for patients with head and neck cancer and non-small
cell lung cancer.
- Patients may have received cetuximab, panitumumab or erlotinib previously
- Adequate kidney, liver, and bone marrow function
- Life expectancy greater than 3 months
- ECOG performance status = 2
- Normal left ventricular ejection fractions
Exclusion Criteria:
- Chemotherapy or surgery within 4 weeks prior to treatment start
- Radiation treatment within 3 weeks prior to treatment start
- Prior therapy with lapatinib
- Untreated brain metastasis or neurologically unstable CNS metastases
- Any severe or uncontrolled medical condition or other condition that could affect
participation in this study including unstable angina, serious uncontrolled cardiac
arrhythmia, uncontrolled infection, or myocardial infarction = 6 months prior to
study entry
- Diarrhea > grade 1 at baseline
- Patients on a medication or herbal therapy known to inhibit CYP3A4
- Gastrointestinal tract disease resulting in the inability to take oral medication or
a requirement for IV alimentation, prior surgical procedures affecting absorption or
active peptic ulcer disease
- Ongoing ventricular cardiac dysrhythmias of grade >/= 2
- Subjects with a history of serious ventricular arrhythmia (ventricular tachycardia or
ventricular fibrillation >= 3 beats in a row)
- Serious cardiac arrhythmia requiring medication
- QTc interval > 500 msec
- Female patients who are pregnant or breast feeding, or adults who are of reproductive
potential and are unwilling to refrain from conceiving a child during study treatment
- Patients unwilling or unable to comply with the protocol or provide informed consent