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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hopital Foch
• Treatments: Everolimus; Sirolimus

Criteria

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