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

Hopital Foch

Status and phase

Completed

Phase 2

Conditions

Urothelial Cancer

Treatments

Drug: Everolimus (Afinitor®)

Study type

Interventional

Funder types

Other

Identifiers

NCT01801137

2010/23

Details and patient eligibility

About

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

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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