A Trial With Vinflunine in Patients With Metastatic Bladder Cancer and Impaired Renal Function

Inclusion Criteria * Signed informed consent. * Histological or cytological confirmed transitional cell carcinoma of the urothelial tract (mixed histology including transitional cell carcinoma are allowed). * Non-curable unresectable (T4b), locally advanced (lymph node positive (N+)) or metastatic (M1) urothelial carcinoma (including renal pelvic tumours, ureteral tumours, urinary bladder tumours and urethral primary tumours). * No prior antineoplastic chemotherapy or other anti-cancer drugs. Patients who have received neoadjuvant or adjuvant platinum containing chemotherapy and who are diagnosed with loco regional recurrent or metastatic disease after 6 months are eligible. * Creatinine clearance 30 - 60 ml/min (measured by Iohexol or Cr-EDTA technique) * ECOG/WHO Performance Status (PS) 0-1. •≥ 4 weeks since prior major surgery, ≥ 2 weeks since prior minor surgery (i.e. TUR-B) and ≥ 1 week since prior radiation therapy. * Measurable and/or non-measurable disease using the RECIST v 1:1 criteria defined as: * Measurable disease: lesions that can be measured in at least one dimension and which have not been previously irradiated. Longest diameter ≥10 mm or lymph nodes ≥15 mm in short axis with CT scan or MRI. * Non-measurable disease: lesions which have not been previously irradiated, longest diameter \<10 mm or lymph nodes 10-14 mm in short axis with CT scan or MRI, or truly non measurable lesions including bone lesions, ascites, pleural/pericardial effusion, and lym…