A single arm, single center window of opportunity trial of using a combination of metformin
and simvastatin as a neoadjuvant treatment for patients with invasive bladder cancer who are
to undergo cystectomy. The study will assess the feasibility of conducting window of
opportunity trials in invasive bladder cancer the drug combination's affects on a variety of
important clinicopathologic variables.
The goal is to enroll 44 patients within 18 months. An interim analysis will be conducted at
12 months, and the study will be prematurely closed if fewer than 10 patients have been
enrolled at that time. Patients will be administered 850mg of metformin twice daily along
with 20mg of Simvastatin. Patients will be enrolled following the formal diagnosis of
invasive bladder cancer or at first visit following referral to the London Health Sciences
Center (LHSC). Patient's will receive metformin and simvastatin from the time of enrollment
until the night prior to their operation in the absence of safety or tolerability concerns.