Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer
NCT ID: NCT00457691
Last Updated: 2015-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
768 participants
INTERVENTIONAL
2007-06-30
2010-03-31
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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1
5 fluorouracil
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
irinotecan
180mg/m2 iv day 1 every 14 days
levo- leucovorin
200mg/m2 iv; day 1 every 14 days
sunitinib
37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period
2
5 fluorouracil
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
irinotecan
180mg/m2 iv day 1 every 14 days
levo- leucovorin
200mg/m2 iv; day 1 every 14 days
placebo
37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period
Interventions
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5 fluorouracil
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
irinotecan
180mg/m2 iv day 1 every 14 days
levo- leucovorin
200mg/m2 iv; day 1 every 14 days
sunitinib
37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period
5 fluorouracil
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
irinotecan
180mg/m2 iv day 1 every 14 days
levo- leucovorin
200mg/m2 iv; day 1 every 14 days
placebo
37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period
Eligibility Criteria
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Inclusion Criteria
* Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated.
* Adequate organ function defined by blood test.
Exclusion Criteria
* Previous full field radiotherapy within the last 4 weeks or limited field radiotherapy within 2 weeks of enrolling into the study. Or previous radiation treatment of more that 30% of the bone marrow.
* History of presence of brain metastasis, spinal cord compression carcinomatous meningitis or leptomeningeal disease.
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
La Plata, Buenos Aires, Argentina
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Santa Fe, Santa Fe Province, Argentina
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Wollongong, New South Wales, Australia
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East Bentleigh, Victoria, Australia
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Frankston, Victoria, Australia
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Fremantle, Western Australia, Australia
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Sankt Pölten, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Sarajevo, , Bosnia and Herzegovina
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Goiânia, Goiás, Brazil
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Curitiba, Paraná, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Santo André, São Paulo, Brazil
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Sofia, Bulgaria, Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Varna, , Bulgaria
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Santiago, RM, Chile
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Santiago, RM, Chile
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Medellín, Antioquia, Colombia
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Pasto, Departamento de Nariño, Colombia
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Nicosia, , Cyprus
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Brno, , Czechia
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Nová Ves pod Pleší, , Czechia
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Příbram, , Czechia
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Berlin, , Germany
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Bochum, , Germany
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Esslingen am Neckar, , Germany
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Frankfurt, , Germany
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Halle, , Germany
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Hanover, , Germany
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Mönchengladbach, , Germany
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Oldenburg, , Germany
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Regensburg, , Germany
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Hong Kong, , Hong Kong
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Kowloon, , Hong Kong
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Tuen Mun, New Territories, , Hong Kong
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Debrecen, , Hungary
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Bangalore, Karnataka, India
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Mumbai, Maharashtra, India
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Mumbai, Maharashtra, India
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Pune, Maharashtra, India
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Pune, Maharashtra, India
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Vellore, Tamil Nadu, India
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Galway, , Ireland
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Acapulco de Juárez, Guerrero, Mexico
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Mexico City, Mexico City, Mexico
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Ciudad Obregón, Sonora, Mexico
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Førde, , Norway
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Tønsberg, , Norway
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Evora, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Santa Maria da Feira, , Portugal
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Cluj-Napoca, Cluj, Romania
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Belgrade, Serbia, Serbia
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Kamenitz, Serbia, Serbia
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Belgrade, , Serbia
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Kamenitz, , Serbia
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Singapore, Singapore, Singapore
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Singapore, Singapore, Singapore
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Observatory, , South Africa
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Panorama, , South Africa
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Parktown, , South Africa
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Port Elizabeth, , South Africa
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Sandton, , South Africa
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Goyang-si, Gyeonggi-do, South Korea
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Daegu, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Alicante, Alicante, Spain
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Elche, Alicante, Spain
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Barcelona, Barcelona, Spain
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Santander, Cantabria, Spain
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Madrid, Madrid, Spain
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Móstoles, Madrid, Spain
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Seville, Sevilla, Spain
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Zaragoza, Zaragoza, Spain
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Gothenburg, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Kaohsiang Hsien, Taiwan, Taiwan
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Changhua, , Taiwan
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Chiayi County, , Taiwan
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Kaohsiung City, , Taiwan
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Kwei-Shan, Taoyuan, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Rachathevee, Bangkok, Thailand
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Muang, Changwat Khon Kaen, Thailand
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Muang, Chiang Mai, Thailand
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Bangkok, , Thailand
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Cherkasy, , Ukraine
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Dnipropetrovsk, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Uzhhorod, , Ukraine
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Northwood, Middlesex, United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
Countries
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References
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Carrato A, Swieboda-Sadlej A, Staszewska-Skurczynska M, Lim R, Roman L, Shparyk Y, Bondarenko I, Jonker DJ, Sun Y, De la Cruz JA, Williams JA, Korytowsky B, Christensen JG, Lin X, Tursi JM, Lechuga MJ, Van Cutsem E. Fluorouracil, leucovorin, and irinotecan plus either sunitinib or placebo in metastatic colorectal cancer: a randomized, phase III trial. J Clin Oncol. 2013 Apr 1;31(10):1341-7. doi: 10.1200/JCO.2012.45.1930. Epub 2013 Jan 28.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6181122
Identifier Type: -
Identifier Source: org_study_id
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