SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
NCT ID: NCT00083889
Last Updated: 2010-01-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
750 participants
INTERVENTIONAL
2004-08-31
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
NONE
Study Groups
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2
Interferon-alfa
3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity
1
SU011248
50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity
Interventions
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Interferon-alfa
3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity
SU011248
50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evidence of measurable disease by radiographic technique
* Eastern Cooperative Oncology Group \[ECOG\] performance status of 0 or 1
Exclusion Criteria
* History of or known brain metastases
* Serious acute or chronic illness or recent history of significant cardiac abnormality
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer Inc
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Jonesboro, Arkansas, United States
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La Jolla, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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New Haven, Connecticut, United States
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New Haven, Connecticut, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Tampa, Florida, United States
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Chicago, Illinois, United States
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Maywood, Illinois, United States
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Kansas City, Kansas, United States
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Overland Park, Kansas, United States
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Louisville, Kentucky, United States
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Covington, Louisiana, United States
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Metairie, Louisiana, United States
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Metairie, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Detoit, Michigan, United States
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Detroit, Michigan, United States
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Farmington Hills, Michigan, United States
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Minneapolis, Minnesota, United States
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Columbus, Mississippi, United States
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Corinth, Mississippi, United States
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Jackson, Mississippi, United States
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Jackson, Mississippi, United States
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Southaven, Mississippi, United States
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Tupelo, Mississippi, United States
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Kansas City, Missouri, United States
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Omaha, Nebraska, United States
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Lebanon, New Hampshire, United States
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New York, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Tulsa, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Memphis, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Tyler, Texas, United States
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Salt Lake City, Utah, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Lismore, New South Wales, Australia
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St Leonards, New South Wales, Australia
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South Brisbane, Queensland, Australia
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Woodville South, South Australia, Australia
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East Melbourne, Victoria, Australia
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Perth, Western Australia, Australia
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Victoria, , Australia
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Paris, Cedex 15, France
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Lyon, , France
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Paris, , France
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Rennes, , France
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Saint-Herblain, , France
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Vandœuvre-lès-Nancy, , France
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Aachen, , Germany
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Essen, , Germany
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Hanover, , Germany
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Ulm, , Germany
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Ulm, , Germany
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Modena, , Italy
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Napoli, , Italy
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Pavia, , Italy
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Roma, , Italy
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Roma, , Italy
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Roma, , Italy
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Moczowego, Warszawa, Poland
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Gdansk, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Obninsk, Kaluga Oblast, Russia
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Chelyabinsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Tomsk, , Russia
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L'Hospitalet de Llobregat, Barcelona, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Pamplona, Navarre, Spain
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Seville, SEVILLA, Spain
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Whitchurch, Cardiff, United Kingdom
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Manchester, Lancashire, United Kingdom
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Northwood, Middlesex, United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Sutton Surrey, , United Kingdom
Countries
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References
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Rini BI, Hutson TE, Figlin RA, Lechuga MJ, Valota O, Serfass L, Rosbrook B, Motzer RJ. Sunitinib in Patients With Metastatic Renal Cell Carcinoma: Clinical Outcome According to International Metastatic Renal Cell Carcinoma Database Consortium Risk Group. Clin Genitourin Cancer. 2018 Aug;16(4):298-304. doi: 10.1016/j.clgc.2018.04.005. Epub 2018 May 4.
de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
Cella D, Michaelson MD, Bushmakin AG, Cappelleri JC, Charbonneau C, Kim ST, Li JZ, Motzer RJ. Health-related quality of life in patients with metastatic renal cell carcinoma treated with sunitinib vs interferon-alpha in a phase III trial: final results and geographical analysis. Br J Cancer. 2010 Feb 16;102(4):658-64. doi: 10.1038/sj.bjc.6605552. Epub 2010 Jan 26.
Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-24. doi: 10.1056/NEJMoa065044.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6181034
Identifier Type: -
Identifier Source: org_study_id
NCT00098657
Identifier Type: -
Identifier Source: nct_alias
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