Urothelial Cancer
Conditions
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
Interventions
Sponsors
Hopital Foch
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Outcome results
None listed