Clinical trial NCT01103544: JAVLOR® Online Non-Interventional Trial
Official title: Usage of Vinflunine i.v. (JAVLOR®) for the Treatment of Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium in Adult Patients After Failure of a Cisplatinum-containing Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transitional Cell Carcinoma
Keywords: TCCU
advanced TCCU
metastatic TCCU
transitional cell carcinoma of the urothelium
advanced transitional cell carcinoma of the urothelium
metastatic transitional cell carcinoma of the urothelium
Cisplatinum failure
Vinflunine
Javlor
daily routine
concomitant antiemetic treatment
concomitant antiobstipative treatment
concomitant antiobstipative diet
patient compliance
quality of life
non-interventional study
Germany
Advanced / metastatic TCCU after Cisplatinum-failure
Lead sponsor: Pierre Fabre Pharma GmbH
Sponsor class: INDUSTRY
Collaborators: name: DocCheck Medical Services GmbH
First posted: 2010-04-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced or metastatic transitional cell carcinoma of the urothelium after failure of a Cisplatinum-containing therapy

Brief summary: Documentation of data concerning tolerability and efficacy of the intravenous treatment with vinflunine performed under daily routine conditions in Germany. The trial focusses on tolerability including the assessment of the usage of anti-emetic and anti-obstipative concomitant treatment as well as on the efficacy of the treatment.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Legally competent male and female patients
* Advanced or metastatic transitional cell carcinoma of the urothelium
* Failure of a prior Cisplatinum-containing treatment
* Performance Status 0 or 1
* Signed patient informed consent

Exclusion Criteria:

* Missing signed patient informed consent
* Performance Status 2 or higher
* Life expectancy \< 2 months
* Brain metastases
* Creatinine-clearance \< 20 ml/min
* Child-Pugh-stadium C
* Prothrombin time \< 50%
* Bilirubin \> 5 x ULN
* Transaminases \> 6 x ULN
* Gamma-Glutamyl-transferase \> 15 x ULN
* Pregnant or breast-feeding women
* Known/suspected hypersensitivity against vinflunine or other vinca-alkaloids
* Recent (within the last 2 weeks) or current severe infections
* Baseline ANC \< 1,500/mm3 or platelets \< 100,000/mm3
* Patients being institutionalised due to court/regulatory order

Primary outcomes:
measure: Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine
timeFrame: 9 months after LPI
Secondary outcomes:
measure: Explorative assessment of Overall Response Rate (ORR)
timeFrame: 9 months after LPI
measure: Anti-emetic comedication
timeFrame: 9 months after LPI
measure: Anti-obstipative diet / comedication
timeFrame: 9 months after LPI
measure: General well-being / quality of life of the patients (patient questionnaire)
timeFrame: 9 months after LPI
measure: Patients' satisfaction with the treatment (patient questionnaire)
timeFrame: 9 months after LPI
measure: Physicians' satisfaction with the treatment
timeFrame: 9 months after LPI
measure: Patients' compliance with regards to the cotreatments (patient questionnaire)
timeFrame: 9 months after LPI
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Pierre Fabre Pharma GmbH
Study officials:
References: