Biomarker predication of efficacy to gemcitabine plus vandetanib in phase II, double blind multicentre randomised controlled trial of gemcitabine placebo in locally advanced or metastatic pancreatic carcinoma

Objectives We investigated the potential of biomarkers to predict efficacy of vandetanib and gemcitabine in patients with locally advanced (N= 41) or metastatic (N= 101) pancreatic cancer in a phase II double-blind multicentre randomised placebo-controlled trial.Methods All patients (ECOG= 0-2) had gemcitabine (1000mg/m2 30min iv weekly for 7 weeks followed by a 1 week break then a cycle of weekly treatment for 3 weeks with a 1 week break), until disease progression and randomly assigned to 300mg/d vandetanib once daily or placebo. The primary outcome measure was overall survival by ITT. A panel of potential biomarkers were tested to predict best survival with vandetanib and gemcitabine.