Chemotherapy refractory metastatic urothelia carcinoma MedDRA version: 9.1 Level: LLT Classification code 10064467 Term: Urothelial carcinoma
Conditions
Sponsors
Lukaskrankenhaus GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: men and women, at least 18 years metastatic urothelial carcinoma prvious chemotherapy with a cis-platin containing regimen life expectancy at least 6 months karnofsky index at least 60% Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Impaired general health status, defined as Karnofsky-Index < 60% Previous treatment with temsirolimus Cardiac failure of NYHA stage 3 or 4 Psychiatric disorder Pregnancy, lactation Second malignant disease (exception: basalioma of skin) in previous 2 years Participation in another therapeutical trial during 60 days preceding study start Contraindications according to SmPC: Hypersensitivity to temsirolimus, its metabolites (including sirolimus), polysorbate 80, or to any of the excipients of temsirolimus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy (in terms of overall survival) of temsirolimus in patients with metastatic urothelial carcinoma with failure of previous cisplatin-containing chemotherapy;Secondary Objective: effects of temsirolimus on quality of life, time to tumor progression, drug safety;Primary end point(s): overall survival | — |
Countries
Germany
Outcome results
None listed