[Targetspezifische Second-line-Therapie des metastasierten Urothelkarzinoms mit Temsirolimus]Target-specific therapy of metastatic urothelial carcinoma with temsirolimus - Targetspezifische Second-line-Therapie des metastasierten Urothelkarzinoms mit Temsirolimus

Conditions: Chemotherapy refractory metastatic urothelia carcinoma
MedDRA version: 9.1Level: LLTClassification code 10064467Term: Urothelial carcinoma

Registration Number: EUCTR2008-008478-30-DE

Lead Sponsor: ukaskrankenhaus GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures