Gemcitabine and cisplatin are two standard chemotherapy drugs used to treat tumors of the urothelial tract. These drugs do not shrink tumors in all patients, however, and when they do, it is generally for a limited amount of time. Scientists are therefore seeking more effective ways to treat these cancers.
The purpose of this study is to evaluate the safety of gemcitabine and cisplatin plus everolimus at different dose levels in patients with advanced urothelial cancers that have grown or spread despite previous treatments. Urothelial cancers include those of the bladder, ureter, urethra, or renal pelvis.
Everolimus is a pill that inhibits a molecule called mTOR, which helps cancer cells grow. Laboratory studies have shown that everolimus appears to improve the activity of cisplatin against cancer cells. Everolimus is currently approved to treat advanced renal cell carcinoma; its use against other cancers is considered investigational.