The Efficacy of RAD 001 as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium

A Multicentre Phase III Trial to Determine the Efficacy of RAD 001 (Everolimus, Afinitor) as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium Which Failed or Progressed After First Line Chemotherapy

A study to determine the efficacy of Everolimus(Afinitor®) as third line therapy in patients with transitional cell carcinoma of the urothelium which failed or progressed after two lines of chemotherapy

Inclusion Criteria:

• Provision of written informed consent
• Male or female aged more than 18 years
• Histologically proven transitional cell carcinoma of the urothelium
• Metastatic or locally advanced disease not amenable to curative surgery and/or radiotherapy
• Recurrence or progression after at least one chemotherapy regimen and for unresectable/advanced disease
• No more than 2 lines of previous chemotherapy..
• Measurable disease (RECIST criteria)
• Previously irradiated lesions are not considered measurable- ECOG performance status of 0, 1 or 2

Exclusion Criteria:

• No prior treatment with anti cancer agents, including radiotherapy, in the last 4 weeks.
• No currently active CNS involvement
• No pregnancy. Women of child bearing potential must have a negative pregnancy test.
• No uncontrolled diabetes
• No symptomatic coronary artery disease, myocardial infarction within the last six months, congestive cardiac failure greater than New York Heart Association (NYHA) class II, uncontrolled or symptomatic cardiac arrhythmia