A Study Evaluating Chemotherapy With Fractionated Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function. (VEFORA)

This is an interventional treatment trial for Advanced Urothelial Cancer focused on measuring Urothelial cancer, renal function impaired. Read More

Inclusion Criteria:

1. . Age < or = 18 years, patients aged 75 years or more will benefit from a geriatric assessment.
2. . Advanced or metastatic urothelial cancer confirmed histologically or cytologically.
3. . Patients liable to receive a first -line chemotherapy for advanced or metastatic urothelial carcinoma.
4. . Measurable disease according to RECIST criteria V1.1.
5. . Patients who received neoadjuvant or adjuvant chemotherapy based on platinum salt must have completed treatment at least 6 months before entering the study.
6. . Performance status < or = 2.
7. . Life expectancy > 3 months.
8. . Patients with creatinine clearance between 40 and 60 ml / min ( according to Cockcroft and Gault ).
9. . Patients having no contra-indication to overhydration.
10. . Satisfactory hematological tests: Neutrophils > 1.5 G / l Platelets > 150 G / l , hemoglobin ≥ 10 g / dl.
11. . Satisfactory liver function tests: total bilirubin < 1.5 x ULN (upper limit of normal), AST (aspartate aminotransferase) and ALT (alanine aminotransferase)<or = 2.5 x ULN (or 5 x ULN if liver metastases).
12. . In case of prior radiotherapy, a minimum of 14 days must relapse between the end of radiotherapy and study entry.
13. . For women of childbearing age , use an effective contraceptive method to study entry and for the duration of the study and 6 months after the last dose of study treatment ; For sexually active fertile men having a partner of childbearing age using effective contraception for the duration of the study and 6 months after the last dose of study treatment.
14. . Patient affiliated to a social security system in France.
15. . Patient signed informed consent before inclusion in the study and before any specific procedure for the study.

Exclusion Criteria:

1. . Any concomitant or previous malignancy within 5 years prior to the study ( with the exception of basal cell or squamous cell carcinoma in situ).
2. . Pregnant or lactating women.
3. . Patients with brain metastases or meningeal or symptoms suggestive of such secondary locations.
4. . Bisphosphonate or Denosumab treatment initiated within 28 days prior to randomization into the study or patient who have started such treatment during the study ( a bisphosphonate or denosumab treatment initiated within a period longer than 28 days before randomization may be continued without change during the study ).
5. . Other concomitant cancer (radiation therapy, radiopharmaceutical agent chemotherapy).
6. . Patients with uncontrolled infection.
7. . Patients with peripheral neuropathy grade> 1, whatever the origin or patients with hearing loss.
8. . Patient with unstable disease (eg: unstable diabetes, poorly controlled hypertension , congestive heart failure or myocardial infarction within 3 months prior to study entry).
9. . Known hypersensitivity to study drugs.
10. . Treatment with any other investigational drug within 30 days before inclusion.
11. . Any psychological condition , familial, sociological or geographical not to comply with medical monitoring and / or procedures in the study protocol.
12. . Patient protected by law.