Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer
NCT ID: NCT00399035
Last Updated: 2016-12-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1254 participants
INTERVENTIONAL
2006-11-30
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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FOLFOX + placebo Cediranib
FOLFOX + placebo Cediranib
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Cediranib Placebo
oral tablet
Xelox + placebo Cediranib
Xelox + placebo Cediranib
XELOX (Capecitabine and Oxaliplatin)
intravenous oxaliplatin 130 mg/ m\^2(day 1) followed by oral capecitabine 1,000 mg/ m\^2twice daily (day 1 to day 15)
Cediranib Placebo
oral tablet
FOLFOX + Cediranib
FOLFOX + Cediranib
Cediranib
oral tablet
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
XELOX + Cediranib
XELOX + Cediranib
Cediranib
oral tablet
XELOX (Capecitabine and Oxaliplatin)
intravenous oxaliplatin 130 mg/ m\^2(day 1) followed by oral capecitabine 1,000 mg/ m\^2twice daily (day 1 to day 15)
Interventions
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Cediranib
oral tablet
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
XELOX (Capecitabine and Oxaliplatin)
intravenous oxaliplatin 130 mg/ m\^2(day 1) followed by oral capecitabine 1,000 mg/ m\^2twice daily (day 1 to day 15)
Cediranib Placebo
oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Carcinoma of the colon or rectum
* One or more measurable lesions
Exclusion Criteria
* Untreated unstable brain or meningeal metastases
* Specific laboratory ranges
* Specific cardiovascular problems
* Participation in other trials within 30 days
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Jane Robertson
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Buenos Aires, , Argentina
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Capital Federal, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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Resistencia, , Argentina
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Rosario, , Argentina
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Santa Fe, , Argentina
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Ashford, , Australia
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Camperdown, , Australia
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Heidelberg, , Australia
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Hornsby, , Australia
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Liverpool, , Australia
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Waratah, , Australia
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Wodonga, , Australia
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Curitiba, , Brazil
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Goiânia, , Brazil
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Jaú, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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Salvador, , Brazil
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Santo André, , Brazil
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São Paulo, , Brazil
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Varna, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Vratsa, , Bulgaria
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Beijing, , China
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Changchun, , China
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Chengdu, , China
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Chongqing, , China
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Fuzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Nanjing, , China
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Nanning, , China
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Shanghai, , China
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Tianjin, , China
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Brno, , Czechia
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Cheb, , Czechia
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České Budějovice, , Czechia
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Jičín, , Czechia
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Jihlava, , Czechia
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Olomouc, , Czechia
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Ostrava, , Czechia
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Prague, , Czechia
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Pribram - Zdabor, , Czechia
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Šumperk, , Czechia
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Zlín, , Czechia
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Znojmo, , Czechia
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Essen, , Germany
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Freiburg im Breisgau, , Germany
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Goslar, , Germany
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Hamburg, , Germany
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Hildesheim, , Germany
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Mannheim, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Győr, , Hungary
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Kecskemét, , Hungary
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Nyíregyháza, , Hungary
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Szombathely, , Hungary
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Zalaegerszeg, , Hungary
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Hyderabad, , India
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Trivandrum, , India
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Cebu City, , Philippines
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Davao City, , Philippines
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Iloilo City, , Philippines
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Quezon, , Philippines
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Quezon City, , Philippines
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Gliwice, , Poland
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Krakow, , Poland
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Olsztyn, , Poland
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Torun, , Poland
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Wroclaw, , Poland
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Goyang-si, , South Korea
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Seoul, , South Korea
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Bellinzona, , Switzerland
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Lausanne, , Switzerland
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Locarno, , Switzerland
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Zurich, , Switzerland
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Aberdeen, , United Kingdom
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Belfast, , United Kingdom
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Leicester, , United Kingdom
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Manchester, , United Kingdom
Countries
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References
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Smith JC, Brooks L, Hoff PM, McWalter G, Dearden S, Morgan SR, Wilson D, Robertson JD, Jurgensmeier JM. KRAS mutations are associated with inferior clinical outcome in patients with metastatic colorectal cancer, but are not predictive for benefit with cediranib. Eur J Cancer. 2013 Jul;49(10):2424-32. doi: 10.1016/j.ejca.2013.02.023. Epub 2013 Mar 16.
Related Links
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Other Identifiers
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EUDRACT No 2006-001194-14
Identifier Type: -
Identifier Source: secondary_id
HORIZON II
Identifier Type: -
Identifier Source: secondary_id
D8480C00051
Identifier Type: -
Identifier Source: org_study_id