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
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