A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.
NCT ID: NCT00643565
Last Updated: 2019-10-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
154 participants
INTERVENTIONAL
2008-07-29
2019-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bevacizumab + Chemotherapy
Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
Standard chemotherapy
As prescribed
bevacizumab [Avastin]
7.5 mg/kg iv on day 1 of 9 x 3-week cycles, followed by 5 mg/kg iv on days 1 and 15 of each 4-week cycle
Chemotherapy
Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
Standard chemotherapy
As prescribed
Interventions
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Standard chemotherapy
As prescribed
bevacizumab [Avastin]
7.5 mg/kg iv on day 1 of 9 x 3-week cycles, followed by 5 mg/kg iv on days 1 and 15 of each 4-week cycle
Eligibility Criteria
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Inclusion Criteria
* metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma
* adequate bone marrow function
* adequate renal and liver function
* adequate blood clotting
Exclusion Criteria
* tumor invading major blood vessels
* prior systemic anti-tumor treatment
6 Months
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Hôpital Enfants Reine Fabiola
Brussels, , Belgium
Cliniques Universitaires St-Luc
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Instituto Nacional do Cancer - INCA
Rio de Janeiro, Rio de Janeiro, Brazil
Clinica de Oncologia de Porto Alegre - CliniOnco
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Instituto de Oncologia Pediatrica
São Paulo, São Paulo, Brazil
ITACI - Instituto de Tratamento do Cancer Infantil
São Paulo, São Paulo, Brazil
Hospital Santa Marcelina
São Paulo, São Paulo, Brazil
Hospital For Sick Children
Toronto, Ontario, Canada
Pavillion Chul-Chuq
Sainte-Foy, Quebec, Canada
Hospital Luis Calvo Mackenna; Oncologia
Santiago, , Chile
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
CHU Bordeaux; Unite Onco-Hematologie Pediatrique
Bordeaux, , France
Centre Oscar Lambret; Service de Pediatrie
Lille, , France
Centre Leon Berard; Pediatrie
Lyon, , France
Hopital Timone Enfants; Onco Pediatrie
Marseille, , France
Chr De Nantes; Service D'oncologie Pediatrique
Nantes, , France
Institut Curie; Oncologie Medicale
Paris, , France
CHU Hopital Sud; Service d'Hematologie Pediatrique
Rennes, , France
Hopital Des Enfants; Service d Hemato-Oncologie
Toulouse, , France
CHU Hopital d Enfants; Centre hospitalier Universitaire Nancy
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy; Service Pediatrique
Villejuif, , France
University Hospital Essen; Department of Pediatric Oncology
Essen, , Germany
Universitaetsklinikum Freiburg - PS; Partnersite - Onkologie
Freiburg im Breisgau, , Germany
Universitatsklinikum Munster; Padiatrische Hamatologie und Onkologie
Münster, , Germany
Soroka Medical Center
Beersheba, , Israel
Rambam Health Care Campus; Pediatric Hematology Oncology Department
Haifa, , Israel
Schneider Children's Medical Center
Petah Tikva, , Israel
Tel Aviv Sourasky MC, Dana Children's Hospital; Pediatric Hemato-Oncology Clinic
Tel Aviv, , Israel
Ospedale Pediatrico Bambino Gesu
Rome, Lazio, Italy
Istituto Gaslini Ospedale Pediatrico; Dipartimento di Oncoematologia pediatrica
Genoa, Liguria, Italy
Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica
Milan, Lombardy, Italy
Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita
Turin, Piedmont, Italy
U.O.A University Onco-Ematologia Pedicatria; Azienda Ospedaliera A.Meyer
Florence, Tuscany, Italy
Azienda Ospedaliera di Padova; Clinica di Onco-ematologia pediatrica
Padua, Veneto, Italy
Emma Kinderziekenhuis; Dept of Pediatric Oncology
Amsterdam, , Netherlands
Erasmus Mc/Sophia's Childrens Hospital; Dept. of Pediatric Oncology
Rotterdam, , Netherlands
Prinses Maxima Centrum
Utrecht, , Netherlands
Uniwersytet Medyczny W Lublinie; Klinika Hematologii i Onkologii Dzieciecej
Lublin, , Poland
Instytut Pomnik-Centrum Zdrowia Dziecka; Klinika Onkologii
Warsaw, , Poland
Center for Children's Hematology, Oncology and Immunology
Moscow, , Russia
Saint-Petersburg SHI City Clinical Hospital #31
Saint Petersburg, , Russia
Hospital de Cruces
Barakaldo, Vizcaya, Spain
Hospital Universitari Vall d'Hebron; Servicio de Nefrologia
Barcelona, , Spain
Hospital Infantil Universitario Nino Jesus
Madrid, , Spain
Hospital Regional Universitario Carlos Haya;Servicio Oncologia Pediatrica
Málaga, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Onco-Hematologia Pediatrica
Seville, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Birmingham Childrens Hospital; Oncology Dept
Birmingham, , United Kingdom
Bristol Royal Hospital For Children
Bristol, , United Kingdom
Royal Hospital for Sick Children
Edinburgh, , United Kingdom
Royal Hospital For Children
Glasgow, , United Kingdom
St. James's University Hospital; Leeds Regional Paediatric Oncology Unit
Leeds, , United Kingdom
Alder Hey Children s Hospital; Department of Pediatrics
Liverpool, , United Kingdom
Great Ormond Street Hospital; Dept. Of Pediatric Oncology
London, , United Kingdom
Royal Manchester Children's Hospital
Manchester, , United Kingdom
The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit
Newcastle upon Tyne, , United Kingdom
University Hospital Queens Medical Centre; Department of Paediatric Oncology
Nottingham, , United Kingdom
Royal Marsden Hospital; Pediatric Unit
Surrey, , United Kingdom
Countries
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References
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Schoot RA, Chisholm JC, Casanova M, Minard-Colin V, Geoerger B, Cameron AL, Coppadoro B, Zanetti I, Orbach D, Kelsey A, Rogers T, Guizani C, Elze M, Ben-Arush M, McHugh K, van Rijn RR, Ferman S, Gallego S, Ferrari A, Jenney M, Bisogno G, Merks JHM. Metastatic Rhabdomyosarcoma: Results of the European Paediatric Soft Tissue Sarcoma Study Group MTS 2008 Study and Pooled Analysis With the Concurrent BERNIE Study. J Clin Oncol. 2022 Nov 10;40(32):3730-3740. doi: 10.1200/JCO.21.02981. Epub 2022 Jun 16.
Ferrari A, Merks JHM, Chisholm JC, Orbach D, Brennan B, Gallego S, van Noesel MM, McHugh K, van Rijn RR, Gaze MN, Martelli H, Bergeron C, Corradini N, Minard-Colin V, Bisogno G, Geoerger B, Caron HN, De Salvo GL, Casanova M. Outcomes of metastatic non-rhabdomyosarcoma soft tissue sarcomas (NRSTS) treated within the BERNIE study: a randomised, phase II study evaluating the addition of bevacizumab to chemotherapy. Eur J Cancer. 2020 May;130:72-80. doi: 10.1016/j.ejca.2020.01.029. Epub 2020 Mar 13.
Chisholm JC, Merks JHM, Casanova M, Bisogno G, Orbach D, Gentet JC, Thomassin-Defachelles AS, Chastagner P, Lowis S, Ronghe M, McHugh K, van Rijn RR, Hilton M, Bachir J, Furst-Recktenwald S, Geoerger B, Oberlin O; European paediatric Soft tissue sarcoma Study Group (EpSSG) and the European Innovative Therapies for Children with Cancer (ITCC) Consortium. Open-label, multicentre, randomised, phase II study of the EpSSG and the ITCC evaluating the addition of bevacizumab to chemotherapy in childhood and adolescent patients with metastatic soft tissue sarcoma (the BERNIE study). Eur J Cancer. 2017 Sep;83:177-184. doi: 10.1016/j.ejca.2017.06.015. Epub 2017 Aug 23.
Other Identifiers
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2007-005017-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BO20924
Identifier Type: -
Identifier Source: org_study_id
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