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Efficacy of Combination of Trastuzumab to Gemcitabine - Platinum Advanced or Metastatic Urothelial Carcinoma (CVH-CT02)

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ClinicalTrials.gov Identifier: NCT01828736
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : February 6, 2017
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Recurrent Bladder Cancer Stage IV Bladder Cancer Transitional Cell Carcinoma of the Bladder Biological: Trastuzumab Drug: Gemcitabine Drug: Carboplatin Drug: Cisplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Phase 2 Trial of Gemcitabine - Platinum With or Without Trastuzumab in Advanced or Metastatic Urothelial Carcinoma With HER2 Overexpression
Actual Study Start Date : February 9, 2004
Actual Primary Completion Date : February 23, 2010
Actual Study Completion Date : February 23, 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm A: Platinum + Gemcitabine

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

 Drug: Gemcitabine
Given IV, 1000 mg/m² BSA on Day 1 and Day 8 every 21 days
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • Gemzar
  • gemcitabin hydrochloride

Drug: Carboplatin
Given IV: AUC 5 on Day 1 every 21 days
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin

Drug: Cisplatin
Given IV, 70 mg/m² BSA on day 1 every 21 days
Other Names:
  • cis-Diamminedichloroplatinum(II)
  • Platinum Diamminodichloride
  • Diamminodichloride, Platinum
  • cis-Platinum
  • cis Platinum
  • Dichlorodiammineplatinum
  • cis-Diamminedichloroplatinum
  • cis Diamminedichloroplatinum
  • cis-Dichlorodiammineplatinum(II)
  • Platinol
  • Platidiam
  • Platino
  • NSC-119875
  • Biocisplatinum
Experimental: Arm B: Platinum+Gemcitabine+Trastuzumab

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

 Biological: Trastuzumab
Bottles of 150 mg; Charging dose: 8mg/kg then 6mg/kg every 21 days given IV
Other Names:
  • anti-c-erB-2
  • Herceptin
  • MOAB HER2

Drug: Gemcitabine
Given IV, 1000 mg/m² BSA on Day 1 and Day 8 every 21 days
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • Gemzar
  • gemcitabin hydrochloride

Drug: Carboplatin
Given IV: AUC 5 on Day 1 every 21 days
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin

Drug: Cisplatin
Given IV, 70 mg/m² BSA on day 1 every 21 days
Other Names:
  • cis-Diamminedichloroplatinum(II)
  • Platinum Diamminodichloride
  • Diamminodichloride, Platinum
  • cis-Platinum
  • cis Platinum
  • Dichlorodiammineplatinum
  • cis-Diamminedichloroplatinum
  • cis Diamminedichloroplatinum
  • cis-Dichlorodiammineplatinum(II)
  • Platinol
  • Platidiam
  • Platino
  • NSC-119875
  • Biocisplatinum


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free survival [ Time Frame: Participants will be followed from radomization until progression or death, up to 3 years ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: Objective Response Rate will be assessed during treatment period, every 3 cycles, up to 7 months ]
  2. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Participants will be followed all along the study period, an expected average of 3 years ]
    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.

  3. Quality of life [ 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 ]
    Quality of Life will be assessed according to the EORTC QLQ-C30 Version 3 questionnaire

  4. Overall survival [ Time Frame: Participants will be followed from randomization until death or lost of follow-up, up to 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Transitional cell carcinoma of the urothelium or bladder histologically proven stage IV AJCC [locally advanced (T4b and / or N + M0) unresectable or metastatic (M1)]
  • Tumor and / or metastasis overexpressing HER2 immunohistochemistry (IHC 3 +) or IHC 2 + and FISH +. Centralized analysis.
  • Measurable disease with at least one lesion with a diameter> 2 cm for conventional methods (clinical examination, CT or MRI) or> 1 cm for the helical scanner. In case of single metastasis, metastatic disease should be histologically proven
  • Age ≥ 18 years and ≤80 years
  • Life expectancy> 3 months,
  • Index performance status <2 according to ECOG PS,
  • No prior chemotherapy other than adjuvant and / or neoadjuvant chemotherapy, without Herceptin ® and complete for more than 6 months (naive to any previous chemotherapy in the metastatic setting)
  • No radiotherapy within 4 weeks prior to inclusion,
  • Normal cardiac function as measured by ejection fraction (LVEF> 50%),
  • Blood and liver satisfactory constants:

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:

  • Concurrent treatment with an experimental drug, participation in another clinical trial within <30 days
  • Patients previously treated with Herceptin ®, or another treatment targeting growth factors EGF (eg Iressa ®, Tarceva ®)
  • Existence of a severe pulmonary disease, liver or kidney is likely to be exacerbated by the treatment,
  • Other medical conditions: congestive heart failure or angina pectoris even if medically controlled failure, history of myocardial infarction before entering the trial, hypertension or uncontrolled arrhythmias, significant valvular disease,
  • Patient with dyspnoea at rest or requiring oxygen therapy or with respiratory failure,
  • Presence of a severe infection requiring antibiotics,
  • Presence of CNS metastases or meningeal
  • History of another malignancy uncured or cured for less than 5 years (except basal cell carcinoma, papillary thyroid carcinoma in situ of the cervix treated)
  • Pregnant or lactating or not using effective contraception Women,
  • For Cisplatin only: carrying a serious neurological disease, current events devices> NCI grade 2 neuropathy, hearing loss, creatinine clearance <60 ml / min, the patient can not support a patient hydration.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828736


Locations
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Belgium
Cliniques saint Luc - Université Catholique de Louvain
Bruxelles, Belgium, 1200
France
CHU de Besançon
Besançon, France, 25000
CHU Hôpital Saint André
Bordeaux, France, 33000
Hôpital Jean Perrin
Clermont Ferrand, France, 63000
Centre Hospitalier Départemental de la Vendée
La Roche-sur-yon, France, 85000
Clinique Victor Hugo
Le Mans, France, 72000
CHU Hôpital La Timone
Marseille, France, 13005
Institut Paoli Calmettes
Marseille, France, 13009
Clinique Hartmann
Neuilly-Sur-Seine, France, 92200
Curie Institute
Paris, France, 75005
Hôpital Saint Louis
Paris, France, 75010
Groupe Hospitalier Saint Joseph Paris
Paris, France, 75014
Hôpital Cochin
Paris, France, 75014
Hôpital Européen Georges Pompidou
Paris, France, 75015
Hôpital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Roche Pharma AG
Investigators
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Principal Investigator: Stéphane Oudard, MD, PhD. Hôpital Européen Georges Pompidou, Paris (France)
Principal Investigator: Philippe Beuzeboc, MD Curie Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
ClinicalTrials.gov Identifier: NCT01828736    
Other Study ID Numbers: CVH-CT 02
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Keywords provided by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie:
Urothelial carcinoma
Trastuzumab
Treatment
Additional relevant MeSH terms:
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Carcinoma
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Cisplatin
 Carboplatin
Trastuzumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological