PK Trial of Sorafenib & Erlotinib in Patients With Refractory Solid Tumors

Compared with supportive care alone, erlotinib has been associated with improved overall
survival in patients with Refractory Solid Tumors; however, this absolute benefit is limited
for the majority of patients. Incorporating other biologic agents into the second- or
third-line treatment setting may prove to be a successful strategy in improving treatment
efficacy (which has been recently demonstrated in several tumor types). Additionally,
recent data suggest that smoking may influence the pharmacokinetic (PK) profile of erlotinib
by increasing the metabolic clearance. Data suggest that the geometric mean erlotinib
AUC(0-inf) and C(24h) are significantly decreased in smokers compared with nonsmokers
(Hamilton et al. 2006). For this reason, this trial will enroll separate cohorts of
patients who are current smokers and patients who are nonsmokers. Nonsmokers are patients
who have not consumed tobacco or nicotine-containing products for 1 year before the start of
the study. Patients classified as current smokers must have smoked a minimum of 10
cigarettes per day for ≥1 year.