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

Phase 2

Completed

Brief 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Afinitor	Everolimus (Afinitor®)	Treatment by Afinitor 10 mg per day

Primary Outcome Measures

Name	Time	Method
Progression-free survival rate at 12 weeks	3 months	If a patient has not had an event, Progression-free survival is censored at the date of last adequate tumor assessment.

Secondary Outcome Measures

Name	Time	Method

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial