Efficacy of Combination of Trastuzumab to Gemcitabine - Platinum Advanced or Metastatic Urothelial Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

February 9, 2004

Primary Completion Date

February 23, 2010

Study Completion Date

February 23, 2010

Conditions
Recurrent Bladder CancerStage IV Bladder CancerTransitional Cell Carcinoma of the Bladder
Interventions
BIOLOGICAL

Trastuzumab

Bottles of 150 mg; Charging dose: 8mg/kg then 6mg/kg every 21 days given IV

DRUG

Gemcitabine

Given IV, 1000 mg/m² BSA on Day 1 and Day 8 every 21 days

DRUG

Carboplatin

Given IV: AUC 5 on Day 1 every 21 days

DRUG

Cisplatin

Given IV, 70 mg/m² BSA on day 1 every 21 days

Trial Locations (15)

1200

Cliniques saint Luc - Université Catholique de Louvain, Brussels

13005

CHU Hôpital La Timone, Marseille

13009

Institut Paoli Calmettes, Marseille

25000

CHU de Besançon, Besançon

33000

CHU Hôpital Saint André, Bordeaux

63000

Hôpital Jean Perrin, Clermont-Ferrand

72000

Clinique Victor Hugo, Le Mans

75005

Curie Institute, Paris

75010

Hôpital Saint Louis, Paris

75014

Groupe Hospitalier Saint Joseph Paris, Paris

Hôpital Cochin, Paris

75015

Hôpital Européen Georges Pompidou, Paris

85000

Centre Hospitalier Départemental de la Vendée, La Roche-sur-Yon

92151

Hôpital Foch, Suresnes

92200

Clinique Hartmann, Neuilly-sur-Seine

All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

lead

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

OTHER

NCT01828736 - Efficacy of Combination of Trastuzumab to Gemcitabine - Platinum Advanced or Metastatic Urothelial Carcinoma | Biotech Hunter | Biotech Hunter