A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy
NCT ID: NCT00738530
Last Updated: 2016-06-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
649 participants
INTERVENTIONAL
2004-06-30
2008-09-30
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
DOUBLE
Study Groups
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Bevacizumab + IFN-Alfa-2A
Bevacizumab infusions will be administered every 2 weeks at a dose of 10 milligram per kilogram (mg/kg) for 52 weeks or until disease progression or unacceptable toxicity. Interferon alfa-2a (IFN-Alfa-2A) will be administered 3 times per week as a subcutaneous injection at a dose of 9 million international units (MIU) for 52 weeks or until disease progression or major toxicity.
Bevacizumab [Avastin]
10 mg/kg IV every 2 weeks
Interferon alfa 2a [Roferon]
9 MIU SC 3 times/week
Placebo + IFN-Alfa-2A
Placebo matched with Bevacizumab infusions will be administered every 2 weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A will be administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
Interferon alfa 2a [Roferon]
9 MIU SC 3 times/week
Placebo
IV every 2 weeks
Interventions
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Bevacizumab [Avastin]
10 mg/kg IV every 2 weeks
Interferon alfa 2a [Roferon]
9 MIU SC 3 times/week
Placebo
IV every 2 weeks
Eligibility Criteria
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Inclusion Criteria
* nephrectomy;
* absence of proteinuria.
Exclusion Criteria
* major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start;
* presence of brain metastases or spinal cord compression;
* ongoing need for full dose anticoagulants;
* uncontrolled hypertension;
* clinically significant cardiovascular disease.
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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Adelaide, , Australia
Adelaide, , Australia
Brisbane, , Australia
Canberra, , Australia
Frankston, , Australia
Kurralta Park, , Australia
Melbourne, , Australia
Perth, , Australia
Sydney, , Australia
Sydney, , Australia
Antwerp, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Wilrijk, , Belgium
Chomutov, , Czechia
České Budějovice, , Czechia
Hradec Králové, , Czechia
Pilsen, , Czechia
Tampere, , Finland
Turku, , Finland
Angers, , France
Bordeaux, , France
Caen, , France
Clermont-Ferrand, , France
Grenoble, , France
Lille, , France
Limoges, , France
Lyon, , France
Marseille, , France
Nice, , France
Poitiers, , France
Saint-Herblain, , France
Strasbourg, , France
Suresnes, , France
Toulouse, , France
Villejuif, , France
Berlin, , Germany
Darmstadt, , Germany
Hamburg, , Germany
Hanover, , Germany
Mannheim, , Germany
Marburg, , Germany
München, , Germany
Planegg, , Germany
Budapest, , Hungary
Szombathely, , Hungary
Holon, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Ẕerifin, , Israel
Livorno, , Italy
Milan, , Italy
Milan, , Italy
Modena, , Italy
Napoli, , Italy
Perugia, , Italy
Roma, , Italy
Rozzano, , Italy
Torino, , Italy
Amsterdam, , Netherlands
Nijmegen, , Netherlands
Ålesund, , Norway
Oslo, , Norway
Stavanger, , Norway
Trondheim, , Norway
Bydgoszcz, , Poland
Krakow, , Poland
Lodz, , Poland
Olsztyn, , Poland
Tarnów, , Poland
Warsaw, , Poland
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Obninsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Singapore, , Singapore
Singapore, , Singapore
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Granada, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Pontevedra, , Spain
Santander, , Spain
Valencia, , Spain
Zaragoza, , Spain
Basel, , Switzerland
Bern, , Switzerland
Geneva, , Switzerland
Chang Gung, , Taiwan
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Countries
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References
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Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
Other Identifiers
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2004-000282-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BO17705
Identifier Type: -
Identifier Source: org_study_id
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