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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00399035
Registration number
NCT00399035
Ethics application status
Date submitted
13/11/2006
Date registered
14/11/2006
Date last updated
28/12/2016
Titles & IDs
Public title
Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer
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Scientific title
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.
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Secondary ID [1]
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EUDRACT No 2006-001194-14
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Secondary ID [2]
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D8480C00051
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Universal Trial Number (UTN)
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Trial acronym
HORIZON II
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cediranib
Treatment: Drugs - FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
Treatment: Drugs - XELOX (Capecitabine and Oxaliplatin)
Treatment: Drugs - Cediranib Placebo
Placebo comparator: FOLFOX + placebo Cediranib - FOLFOX + placebo Cediranib
Placebo comparator: Xelox + placebo Cediranib - Xelox + placebo Cediranib
Experimental: FOLFOX + Cediranib - FOLFOX + Cediranib
Experimental: XELOX + Cediranib - XELOX + Cediranib
Treatment: Drugs: Cediranib
oral tablet
Treatment: Drugs: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Treatment: Drugs: 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)
Treatment: Drugs: Cediranib Placebo
oral tablet
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival
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Assessment method [1]
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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.
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Timepoint [1]
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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.
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Primary outcome [2]
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Overall Survival
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Assessment method [2]
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Timepoint [2]
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Baseline through to date of death upto and including data cut off date of 21/03/10
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Secondary outcome [1]
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Overall Response Rate
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Assessment method [1]
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Objective tumour response(defined as a confirmed response of CR or PR).The definition for a confirmed response was met when an initial RECIST response of PR/CR was confirmed at the next scheduled visit as a PR/CR according to an evaluable assessment.Intervening assessments of non-evaluable or stable disease were allowable as long as the initial RECIST response was confirmed.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 lesi
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Timepoint [1]
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Baseline through to date of death upto and including data cut off date of 21/03/10
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Secondary outcome [2]
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Best Percentage Change in Tumour Size
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Assessment method [2]
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Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions
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Timepoint [2]
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Baseline through to date of death upto and including data cut off date of 21/03/10
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Secondary outcome [3]
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Duration of Response
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Assessment method [3]
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Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies.
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Timepoint [3]
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Treatment period from initial response up until data cut-off date of 21/03/10
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Secondary outcome [4]
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Rate of Resection of Liver Metastases
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Assessment method [4]
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Number of patients undergoing liver resection, based on patients with liver disease at baseline
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Timepoint [4]
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Post-randomisation until end of study
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Secondary outcome [5]
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Time to Wound Healing Complications
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Assessment method [5]
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Number of days from post-randomisation surgery until wound healing complications
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Timepoint [5]
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Post-randomisation until end of study
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Eligibility
Key inclusion criteria
* Written Informed Consent
* Carcinoma of the colon or rectum
* One or more measurable lesions
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Minimum age
18
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Maximum age
130
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2006
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2016
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Sample size
Target
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Accrual to date
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Final
1254
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Recruitment in Australia
Recruitment state(s)
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Research Site - Ashford
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- Ashford
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- Camperdown
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- Heidelberg
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- Hornsby
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- Liverpool
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- Waratah
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- Wodonga
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Argentina
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Buenos Aires City
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Ciudad de Buenos Aires
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00399035
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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Jane Robertson
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AstraZeneca
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00399035
Download to PDF