JAVLOR Association Study in CDDP-unfit Patients With Advanced Transitional Cell Carcinoma: Gemcitabine Versus Carboplatin

Inclusion Criteria: * Man or woman aged ≥ 18 years and \< 80 years * Signed written informed consent * Histologically confirmed diagnosis of locally advanced or metastatic predominantly transitional cell carcinoma of the urothelium (TCCU) * Ineligibility for cisplatin-based therapy because of at least one of the following two medical conditions: * Calculated creatinine clearance (Cockcroft-Gault formula)\< 60 mL/min * New York Heart Association Classification Stage II-III Congestive Heart Failure (documented by medical history) * "Measurable" disease with at least one uni-dimensional lesion according to RECIST guideline (version 1.1) * ECOG performance status of 0 or 1 * Estimated life expectancy of at least 12 weeks * Patient without prior systemic anticancer therapy unless if it had been administered as neoadjuvant or adjuvant chemotherapy (CT) for TCCU and if the patient has documented relapse ≥ 6 months after the last dose of CT (prior intravesical CT allowed) * Adequate bone marrow and hepatic functions as evidenced by: * Absolute Neutrophil Count ≥ 2,000/mm3 (≥ 2.0 x 109/L) * Haemoglobin ≥ 10 g/dL * Platelet count ≥ 100,000/mm3 * Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) * Transaminases ≤ 2.5 x ULN \[≤ 5 x ULN only in case of liver metastasis\] * Absence of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions should be assessed wi…