A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy
A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Avastin Plus Roferon Compared With Placebo Plus Roferon on Overall Survival and Tumor Assessment in Nephrectomised Patients With Metastatic Clear Cell Renal Cell Carcinoma
2 other identifiers
interventional
649
18 countries
104
Brief Summary
This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (\>)500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2004
Typical duration for phase_3
104 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 19, 2008
CompletedFirst Posted
Study publicly available on registry
August 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
June 23, 2016
CompletedJune 23, 2016
May 1, 2016
4.3 years
August 19, 2008
March 22, 2016
May 16, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Who Died
Baseline up to 4.25 years
Overall Survival (OS) Duration
Duration of survival was defined as the time between the date of randomization and date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. Kaplan-Meier estimates were used for analysis.
Baseline until death (up to 4.25 years)
Secondary Outcomes (8)
Percentage of Participants With Disease Progression or Death
Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
Time to Progression (TTP) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
Percentage of Participants With Treatment Failure
Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
Time to Treatment Failure (TTF) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
- +3 more secondary outcomes
Study Arms (2)
Bevacizumab + IFN-Alfa-2A
EXPERIMENTALBevacizumab 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.
Placebo + IFN-Alfa-2A
PLACEBO COMPARATORPlacebo 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.
Interventions
Eligibility Criteria
You may qualify if:
- metastatic renal cell cancer (clear cell type);
- nephrectomy;
- absence of proteinuria.
You may not qualify if:
- prior systemic treatment for metastatic renal cell cancer;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (104)
Unknown Facility
Adelaide, 5011, Australia
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Adelaide, 5041, Australia
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Brisbane, 4006, Australia
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Canberra, 2606, Australia
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Frankston, 3199, Australia
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Kurralta Park, 5037, Australia
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Melbourne, 3128, Australia
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Perth, 6009, Australia
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Sydney, 2031, Australia
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Sydney, 2139, Australia
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Antwerp, 2020, Belgium
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Brussels, 1000, Belgium
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Brussels, 1200, Belgium
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Wilrijk, 2610, Belgium
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Chomutov, 430 12, Czechia
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České Budějovice, 370 87, Czechia
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Hradec Králové, 500 05, Czechia
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Pilsen, 305 99, Czechia
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Tampere, 33520, Finland
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Turku, 20520, Finland
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Angers, 49933, France
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Bordeaux, 33075, France
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Caen, 14076, France
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Clermont-Ferrand, 63011, France
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Grenoble, 38043, France
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Lille, 59020, France
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Limoges, 87042, France
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Lyon, 69373, France
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Marseille, 13273, France
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Nice, 06189, France
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Poitiers, 86021, France
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Saint-Herblain, 44805, France
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Strasbourg, 67091, France
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Suresnes, 92151, France
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Toulouse, 31052, France
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Villejuif, 94805, France
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Berlin, Germany
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Darmstadt, 64283, Germany
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Hamburg, Germany
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Hanover, 30449, Germany
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Mannheim, 68167, Germany
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Marburg, 35043, Germany
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München, 81377, Germany
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Planegg, Germany
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Budapest, 1122, Hungary
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Szombathely, 9700, Hungary
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Holon, 58100, Israel
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Ramat Gan, 52621, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 6423906, Israel
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Ẕerifin, 70300, Israel
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Livorno, 57100, Italy
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Milan, 20133, Italy
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Milan, 20162, Italy
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Modena, 41100, Italy
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Napoli, 80131, Italy
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Perugia, 06122, Italy
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Roma, 00144, Italy
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Rozzano, 20089, Italy
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Torino, 10126, Italy
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Amsterdam, 1081 HV, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Ã…lesund, 6026, Norway
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Oslo, 0310, Norway
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Stavanger, 4068, Norway
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Trondheim, 7000, Norway
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Bydgoszcz, 85-796, Poland
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Krakow, 31-826, Poland
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Lodz, 94-306, Poland
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Olsztyn, 10-228, Poland
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Tarnów, 33-100, Poland
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Warsaw, 00-909, Poland
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Moscow, 105229, Russia
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Moscow, 107005, Russia
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Moscow, 115478, Russia
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Moscow, 125284, Russia
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Moscow, 129128, Russia
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Moscow, Russia
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Obninsk, 249020, Russia
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Saint Petersburg, 197758, Russia
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Saint Petersburg, Russia
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Singapore, 119074, Singapore
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Singapore, 169610, Singapore
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, 08041, Spain
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Granada, 18014, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Málaga, 29010, Spain
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Pontevedra, 36002, Spain
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Santander, 39008, Spain
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Valencia, 46009, Spain
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Zaragoza, 50009, Spain
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Basel, 4031, Switzerland
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Bern, 3010, Switzerland
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Geneva, 1205, Switzerland
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Chang Gung, Taiwan
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Kaohsiung City, 807, Taiwan
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Taichung, 407, Taiwan
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Taipei, 00112, Taiwan
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London, NW3 2QG, United Kingdom
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London, SE1 9RT, United Kingdom
Unknown Facility
Manchester, M2O 4BX, United Kingdom
Related Publications (1)
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.
PMID: 37146227DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2008
First Posted
August 20, 2008
Study Start
June 1, 2004
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
June 23, 2016
Results First Posted
June 23, 2016
Record last verified: 2016-05