Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer
HORIZON II
A Randomised, Double-blind, Phase III Study to Compare the Efficacy and Safety of Cediranib (AZD2171, RECENTIN™) When Added to 5 Fluorouracil, Leucovorin and Oxaliplatin (FOLFOX) or Capecitabine and Oxaliplatin (XELOX) With the Efficacy and Safety of Placebo When Added to FOLFOX or XELOX in Patients With Previously Untreated Metastatic Colorectal Cancer.
3 other identifiers
interventional
1,254
15 countries
90
Brief Summary
The purpose of this study is to determine if Cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2006
Longer than P75 for phase_3
90 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
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 13, 2006
CompletedFirst Posted
Study publicly available on registry
November 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedResults Posted
Study results publicly available
October 30, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedDecember 28, 2016
October 1, 2016
3.3 years
November 13, 2006
March 29, 2012
November 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-free Survival
RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression \[non-PD\]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.
RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.
Overall Survival
Number of months from randomisation to the date of death from any cause
Baseline through to date of death upto and including data cut off date of 21/03/10
Secondary Outcomes (5)
Overall Response Rate
Baseline through to date of death upto and including data cut off date of 21/03/10
Best Percentage Change in Tumour Size
Baseline through to date of death upto and including data cut off date of 21/03/10
Duration of Response
Treatment period from initial response up until data cut-off date of 21/03/10
Rate of Resection of Liver Metastases
Post-randomisation until end of study
Time to Wound Healing Complications
Post-randomisation until end of study
Study Arms (4)
FOLFOX + placebo Cediranib
PLACEBO COMPARATORFOLFOX + placebo Cediranib
Xelox + placebo Cediranib
PLACEBO COMPARATORXelox + placebo Cediranib
FOLFOX + Cediranib
EXPERIMENTALFOLFOX + Cediranib
XELOX + Cediranib
EXPERIMENTALXELOX + Cediranib
Interventions
intravenous infusion
intravenous oxaliplatin 130 mg/ m\^2(day 1) followed by oral capecitabine 1,000 mg/ m\^2twice daily (day 1 to day 15)
Eligibility Criteria
You may qualify if:
- Written Informed Consent
- Carcinoma of the colon or rectum
- One or more measurable lesions
You may not qualify if:
- Adjuvant/neoadjuvant therapy within 6-12 months of study entry
- Untreated unstable brain or meningeal metastases
- Specific laboratory ranges
- Specific cardiovascular problems
- Participation in other trials within 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (90)
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, 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
Related Publications (1)
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.
PMID: 23510802DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Jane Robertson
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2006
First Posted
November 14, 2006
Study Start
November 1, 2006
Primary Completion
March 1, 2010
Study Completion
August 1, 2016
Last Updated
December 28, 2016
Results First Posted
October 30, 2012
Record last verified: 2016-10