Study of Acitretin to Treat Skin Rash Caused by Erlotinib (a Chemotherapy Drug)

This is a pilot trial with an initial target sample of 32 evaluable subjects. The study will
last up to 12 weeks per subject and up to 9 months for the entire study. Cancer patients
beginning antineoplastic therapy with the EGFR inhibitor erlotinib will be enrolled in this
trial. Patients beginning erlotinib therapy will simultaneously initiate a skin care regimen
consisting of twice daily application of Eucerin,TM Aveeno,TM or CeraveTM moisturizing cream
and daily application of SPF 15 or greater sunscreen.

Those patients who develop rash of CTCAE Grade 2 or higher will be referred to us by their
primary oncologist. Upon onset of the cutaneous eruption, the oncologist will initiate
therapy with doxycycline (100 mg twice daily; those allergic to doxycycline will instead
receive cephalexin, 250 mg twice daily).

On evaluation by the Principal Investigator, patients with insufficient response to a two
week course of doxycycline (continued CTCAE Grade 2 or higher rash) will begin therapy with
low-dose acitretin (10 mg/day). Patients will continue to receive 10 mg/day acitretin and
will be followed for 12 weeks, after which they will be treated off-study according to an
individualized regimen agreed upon by the patient and treating oncologist.

Patients who continue to have unacceptable skin eruptions and who require off-study dose
reduction or interruption of erlotinib despite acitretin treatment, as well as those
patients who develop CTCAE Grade 3 or higher toxicity presumptively due to acitretin, will
be considered non-responders for this study. These patients will be treated off-study.