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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Platinum + Gemcitabine | Active Comparator | Gemcitabine = 1 000 mg/m2 Day1 and Day8 given every 21 days IV + If Creatinin Clearance > 60 ml/min : Cisplatin = Day 1: 70 mg/m² given every 21 days If Creatinin Clearance < 60 ml/min : Carboplatin = Day 1: AUC 5 given every 21 days |
|
| Arm B: Platinum+Gemcitabine+Trastuzumab | Experimental | Trastuzumab: Charging dose = 8mg/kg on day 1; then 6mg/kg every 21 days given IV + Gemcitabine = 1 000 mg/m2 Day1 and Day8 given every 21 days IV + If Creatinin Clearance > 60 ml/min : Cisplatin = Day 1: 70 mg/m² given every 21 days If Creatinin Clearance < 60 ml/min : Carboplatin = Day 1: AUC 5 given every 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Biological | Bottles of 150 mg; Charging dose: 8mg/kg then 6mg/kg every 21 days given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free survival | Participants will be followed from radomization until progression or death, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | 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. |
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Inclusion Criteria:
Hematological criteria: - Neutrophils> 1.5 x 109 / L, - Chips> 100 x 109 / L - Hemoglobin> 10 g / dL, Liver function: - Alkaline phosphatase (unless bone metastases) <2 x N - Total bilirubin <1.5 x N - transaminases (AST, ALT) <1.5 x N, renal Constants: - Creatinine clearance > 30 ml / min (Cockcroft and Gault, cf. Annex XV protocol)
- Patient's written consent after full information.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stéphane Oudard, MD, PhD. | Hôpital Européen Georges Pompidou, Paris (France) | Principal Investigator |
| Philippe Beuzeboc, MD | Curie Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques saint Luc - Université Catholique de Louvain | Brussels | 1200 | Belgium | |||
| CHU de Besançon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25459391 | Derived | 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. |
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| Gemcitabine | Drug | Given IV, 1000 mg/m² BSA on Day 1 and Day 8 every 21 days |
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| Carboplatin | Drug | Given IV: AUC 5 on Day 1 every 21 days |
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| Cisplatin | Drug | Given IV, 70 mg/m² BSA on day 1 every 21 days |
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| 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 | 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 | Participants will be followed from randomization until death or lost of follow-up, up to 3 years |
| Besançon |
| 25000 |
| France |
| CHU Hôpital Saint André | Bordeaux | 33000 | France |
| Hôpital Jean Perrin | Clermont-Ferrand | 63000 | France |
| Centre Hospitalier Départemental de la Vendée | La Roche-sur-Yon | 85000 | France |
| Clinique Victor Hugo | Le Mans | 72000 | France |
| CHU Hôpital La Timone | Marseille | 13005 | France |
| Institut Paoli Calmettes | Marseille | 13009 | France |
| Clinique Hartmann | Neuilly-sur-Seine | 92200 | France |
| Curie Institute | Paris | 75005 | France |
| Hôpital Saint Louis | Paris | 75010 | France |
| Groupe Hospitalier Saint Joseph Paris | Paris | 75014 | France |
| Hôpital Cochin | Paris | 75014 | France |
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| Hôpital Foch | Suresnes | 92151 | France |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D000093542 | Gemcitabine |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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