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

Phase 2 Completed 61 enrolled Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie Roche Pharma AG · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

A multicenter, randomized, Phase 2 trial to study the effectiveness and feasibility of association of trastuzumab with combination chemotherapy in advanced or metastatic bladder cancer patients. Combining monoclonal antibody therapy with combination chemotherapy may improve treatment efficacy on tumours overexpressed HER 2.

Timeline

Start: 2004-02-09
Primary completion: 2010-02-23
Completion: 2010-02-23

Outcome

Missed primary endpoint

paper There was no significant difference between Arms A and B in median PFS (10.2 versus 8.2 months, respectively, p=0.689) PMID 25459391 ↗

Publications

Oudard S, Culine S, Vano Y, Goldwasser F, Theodore C, Nguyen T, Voog E, Banu E, Vieillefond A, Priou F, Deplanque G, Gravis G, Ravaud A, Vannetzel JM, Machiels JP, Muracciole X, Pichon MF, Bay JO, Elaidi R, Teghom C, Radvanyi F, Beuzeboc P. Multicentre randomised phase II trial of gemcitabine+platinum, with or without trastuzumab, in advanced or metastatic urothelial carcinoma overexpressing Her2. Eur J Cancer. 2015 Jan;51(1):45-54. doi: 10.1016/j.ejca.2014.10.009. Epub 2014 Nov 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous
Background	Carboplatin	Small molecule	5 unknown	Intravenous
Background	Cisplatin	Other / unclassified	70 mg/m2	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous