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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

January 21, 2015

Primary Completion Date

April 10, 2018

Study Completion Date

July 15, 2019

Conditions
Advanced Urothelial CancerMetastatic Urothelial Cancer
Interventions
DRUG

Carboplatin

Carboplatin AUC (area under curve) 4,5 at day 1 of each cycle until 6 cycles.

DRUG

Fractionated Cisplatin

Cisplatin 35mg/m² at day 1 and day 8 of each cycle until 6 cycles.

DRUG

Gemcitabine

Gemcitabine 1000mg/m² at day 1 and day 8 of each cycle until 6 cycles.

Trial Locations (18)

13273

Institut Paoli Calmettes, Marseille

14076

Centre Francois Baclesse, Caen

21079

Centre Georges Francois Leclerc, Dijon

25030

Chru Besancon - Hopital Jean Minjoz, Besançon

31052

Institut Claudius Regaud, Toulouse

33076

Institut Bergonie, Bordeaux

34298

Institut Regional Du Cancer Montpellier, Montpellier

37044

Chru Tours, Tours

40024

Ch Mont de Marsan, Mont-de-Marsan

42271

Institut de Cancerologie Lucien Neuwirth, Saint-Priest-en-Jarez

44805

INSTITUT DE CANCEROLOGIE DE L'OUEST - Site René Gauducheau, Saint-Herblain

49933

INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Paul Papin, Angers

67091

CHU de STRASBOURG, Strasbourg

69373

Centre Leon Berard, Lyon

75010

Ap-Hp-Hopital Saint-Louis, Paris

78157

CH VERSAILLES - Hôpital André Mignot, Le Chesnay

87042

CHU LIMOGES - Hôpital Dupuytren, Limoges

94805

Institut Gustave Roussy, Villejuif

All Listed Sponsors
lead

Institut Claudius Regaud

OTHER

NCT02240017 - A Study Evaluating Chemotherapy With Fractionated Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function. | Biotech Hunter | Biotech Hunter