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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Bottles of 150 mg; Charging dose: 8mg/kg then 6mg/kg every 21 days given IV
Given IV, 1000 mg/m² BSA on Day 1 and Day 8 every 21 days
Given IV: AUC 5 on Day 1 every 21 days
Given IV, 70 mg/m² BSA on day 1 every 21 days
Cliniques saint Luc - Université Catholique de Louvain
Brussels, Belgium
CHU de Besançon
Besançon, France
CHU Hôpital Saint André
Bordeaux, France
Hôpital Jean Perrin
Clermont-Ferrand, France
Centre Hospitalier Départemental de la Vendée
La Roche-sur-Yon, France
Clinique Victor Hugo
Le Mans, France
CHU Hôpital La Timone
Marseille, France
Institut Paoli Calmettes
Marseille, France
Clinique Hartmann
Neuilly-sur-Seine, France
Curie Institute
Paris, France
...and 5 more locations
Progression Free survival
Time frame: Participants will be followed from radomization until progression or death, up to 3 years
Objective response rate
Time frame: Objective Response Rate will be assessed during treatment period, every 3 cycles, up to 7 months
Number of participants with adverse events as a measure of safety and tolerability
Toxicity will be classify according to NCI-CTC criteria Version 2.0. Cardiac toxicity will be assessed according to the NYHA (New York Heart Association) criteria.
Time frame: Participants will be followed all along the study period, an expected average of 3 years
Quality of life
Quality of Life will be assessed according to the EORTC QLQ-C30 Version 3 questionnaire
Time frame: Quality of Life will be assessed during the study period, every 3 cycles (Arm A patients) or every 3 months (Arm B patients), up to 3 years
Overall survival
Time frame: Participants will be followed from randomization until death or lost of follow-up, up to 3 years
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