Spots Global Cancer Trial Database for Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer
Official Title: A Multicenter, Randomised, Double-Blind, Phase 3 Study Of Sunitinib In Metastatic Colorectal Cancer Patients Receiving Irinotecan, 5-Fluorouracil And Leucovorin (FOLFIRI) As First Line Treatment
Study ID: NCT00457691
Conditions
Study Description
Brief Summary: The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.
Detailed Description: On June 25, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181122. The DMC determined Study A6181122 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus FOLFIRI versus placebo plus FOLFIRI. No new safety findings were noted. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Patients receiving benefit on treatment as determined by the investigator may remain on study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pfizer Investigational Site, La Plata, Buenos Aires, Argentina
Pfizer Investigational Site, Santa Fe, , Argentina
Pfizer Investigational Site, Wollongong, New South Wales, Australia
Pfizer Investigational Site, East Bentleigh, Victoria, Australia
Pfizer Investigational Site, Frankston, Victoria, Australia
Pfizer Investigational Site, Fremantle, Western Australia, Australia
Pfizer Investigational Site, St. Poelten, , Austria
Pfizer Investigational Site, Wien, , Austria
Pfizer Investigational Site, Bruxelles, , Belgium
Pfizer Investigational Site, Bruxelles, , Belgium
Pfizer Investigational Site, Gent, , Belgium
Pfizer Investigational Site, Leuven, , Belgium
Pfizer Investigational Site, Liege, , Belgium
Pfizer Investigational Site, Sarajevo, , Bosnia and Herzegovina
Pfizer Investigational Site, Goiânia, GO, Brazil
Pfizer Investigational Site, Curitiba, PR, Brazil
Pfizer Investigational Site, Rio de Janeiro, RJ, Brazil
Pfizer Investigational Site, Rio de Janeiro, RJ, Brazil
Pfizer Investigational Site, Santo André, SP, Brazil
Pfizer Investigational Site, Ruse, , Bulgaria
Pfizer Investigational Site, Sofia, , Bulgaria
Pfizer Investigational Site, Sofia, , Bulgaria
Pfizer Investigational Site, Sofia, , Bulgaria
Pfizer Investigational Site, Stara Zagora, , Bulgaria
Pfizer Investigational Site, Varna, , Bulgaria
Pfizer Investigational Site, Oshawa, Ontario, Canada
Pfizer Investigational Site, Ottawa, Ontario, Canada
Pfizer Investigational Site, Santiago, RM, Chile
Pfizer Investigational Site, Santiago, RM, Chile
Pfizer Investigational Site, Medellin, Antioquia, Colombia
Pfizer Investigational Site, Pasto, Narino, Colombia
Pfizer Investigational Site, Nicosia, , Cyprus
Pfizer Investigational Site, Brno, , Czech Republic
Pfizer Investigational Site, Nova Ves Pod Plesi, , Czech Republic
Pfizer Investigational Site, Pribram, , Czech Republic
Pfizer Investigational Site, Berlin, , Germany
Pfizer Investigational Site, Bochum, , Germany
Pfizer Investigational Site, Esslingen, , Germany
Pfizer Investigational Site, Frankfurt, , Germany
Pfizer Investigational Site, Halle, , Germany
Pfizer Investigational Site, Hannover, , Germany
Pfizer Investigational Site, Moenchengladbach, , Germany
Pfizer Investigational Site, Oldenburg, , Germany
Pfizer Investigational Site, Regensburg, , Germany
Pfizer Investigational Site, Hong Kong, , Hong Kong
Pfizer Investigational Site, Kowloon, , Hong Kong
Pfizer Investigational Site, Tuen Mun, New Territories, , Hong Kong
Pfizer Investigational Site, Budapest, , Hungary
Pfizer Investigational Site, Budapest, , Hungary
Pfizer Investigational Site, Budapest, , Hungary
Pfizer Investigational Site, Debrecen, , Hungary
Pfizer Investigational Site, Debrecen, , Hungary
Pfizer Investigational Site, Bangalore, Karnataka, India
Pfizer Investigational Site, Mumbai, Maharashtra, India
Pfizer Investigational Site, Mumbai, Maharashtra, India
Pfizer Investigational Site, Pune, Maharashtra, India
Pfizer Investigational Site, Pune, Maharashtra, India
Pfizer Investigational Site, Vellore, Tamil Nadu, India
Pfizer Investigational Site, Dublin 24, , Ireland
Pfizer Investigational Site, Dublin, , Ireland
Pfizer Investigational Site, Dublin, , Ireland
Pfizer Investigational Site, Galway, , Ireland
Pfizer Investigational Site, Goyang-si, Gyeonggi-do, Korea, Republic of
Pfizer Investigational Site, Daegu, , Korea, Republic of
Pfizer Investigational Site, Incheon, , Korea, Republic of
Pfizer Investigational Site, Seoul, , Korea, Republic of
Pfizer Investigational Site, Seoul, , Korea, Republic of
Pfizer Investigational Site, Seoul, , Korea, Republic of
Pfizer Investigational Site, Seoul, , Korea, Republic of
Pfizer Investigational Site, Mexico, DF, Mexico
Pfizer Investigational Site, Acapulco, Guerrero, Mexico
Pfizer Investigational Site, Ciudad Obregon, Sonora, Mexico
Pfizer Investigational Site, Forde, , Norway
Pfizer Investigational Site, Tonsberg, , Norway
Pfizer Investigational Site, Warszawa, , Poland
Pfizer Investigational Site, Warszawa, , Poland
Pfizer Investigational Site, Warszawa, , Poland
Pfizer Investigational Site, Porto, , Portugal
Pfizer Investigational Site, Porto, , Portugal
Pfizer Investigational Site, Santa Maria da Feira, , Portugal
Pfizer Investigational Site, Évora, , Portugal
Pfizer Investigational Site, Cluj-Napoca, Cluj, Romania
Pfizer Investigational Site, Moscow, , Russian Federation
Pfizer Investigational Site, Moscow, , Russian Federation
Pfizer Investigational Site, Saint Petersburg, , Russian Federation
Pfizer Investigational Site, Saint Petersburg, , Russian Federation
Pfizer Investigational Site, St. Petersburg, , Russian Federation
Pfizer Investigational Site, Belgrade, , Serbia
Pfizer Investigational Site, Sremska Kamenica, , Serbia
Pfizer Investigational Site, Singapore, , Singapore
Pfizer Investigational Site, Singapore, , Singapore
Pfizer Investigational Site, Bratislava, , Slovakia
Pfizer Investigational Site, Bratislava, , Slovakia
Pfizer Investigational Site, Observatory, , South Africa
Pfizer Investigational Site, Panorama, , South Africa
Pfizer Investigational Site, Parktown, , South Africa
Pfizer Investigational Site, Port Elizabeth, , South Africa
Pfizer Investigational Site, Sandton, , South Africa
Pfizer Investigational Site, Elche, Alicante, Spain
Pfizer Investigational Site, Santander, Cantabria, Spain
Pfizer Investigational Site, Mostoles, Madrid, Spain
Pfizer Investigational Site, Alicante, , Spain
Pfizer Investigational Site, Barcelona, , Spain
Pfizer Investigational Site, Madrid, , Spain
Pfizer Investigational Site, Sevilla, , Spain
Pfizer Investigational Site, Zaragoza, , Spain
Pfizer Investigational Site, Goteborg, , Sweden
Pfizer Investigational Site, Stockholm, , Sweden
Pfizer Investigational Site, Uppsala, , Sweden
Pfizer Investigational Site, Changhua, , Taiwan
Pfizer Investigational Site, Chiayi County, , Taiwan
Pfizer Investigational Site, Kaohsiang Hsien, , Taiwan
Pfizer Investigational Site, Kaohsiung, , Taiwan
Pfizer Investigational Site, Kwei-Shan, Taoyuan, , Taiwan
Pfizer Investigational Site, Taichung, , Taiwan
Pfizer Investigational Site, Tainan, , Taiwan
Pfizer Investigational Site, Taipei, , Taiwan
Pfizer Investigational Site, Taipei, , Taiwan
Pfizer Investigational Site, Rachathevee, Bangkok, Thailand
Pfizer Investigational Site, Muang, Chiang Mai, Thailand
Pfizer Investigational Site, Muang, Khon Kaen, Thailand
Pfizer Investigational Site, Bangkok, , Thailand
Pfizer Investigational Site, Cherkasy, , Ukraine
Pfizer Investigational Site, Dnipropetrovsk, , Ukraine
Pfizer Investigational Site, Kyiv, , Ukraine
Pfizer Investigational Site, Lviv, , Ukraine
Pfizer Investigational Site, Uzhgorod, , Ukraine
Pfizer Investigational Site, Northwood, Middlesex, United Kingdom
Pfizer Investigational Site, London, , United Kingdom
Pfizer Investigational Site, Manchester, , United Kingdom
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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