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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
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.
Secondary ID [1] 0 0
EUDRACT No 2006-001194-14
Secondary ID [2] 0 0
D8480C00051
Universal Trial Number (UTN)
Trial acronym
HORIZON II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival
Timepoint [1] 0 0
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.
Primary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
Baseline through to date of death upto and including data cut off date of 21/03/10
Secondary outcome [1] 0 0
Overall Response Rate
Timepoint [1] 0 0
Baseline through to date of death upto and including data cut off date of 21/03/10
Secondary outcome [2] 0 0
Best Percentage Change in Tumour Size
Timepoint [2] 0 0
Baseline through to date of death upto and including data cut off date of 21/03/10
Secondary outcome [3] 0 0
Duration of Response
Timepoint [3] 0 0
Treatment period from initial response up until data cut-off date of 21/03/10
Secondary outcome [4] 0 0
Rate of Resection of Liver Metastases
Timepoint [4] 0 0
Post-randomisation until end of study
Secondary outcome [5] 0 0
Time to Wound Healing Complications
Timepoint [5] 0 0
Post-randomisation until end of study

Eligibility
Key inclusion criteria
* Written Informed Consent
* Carcinoma of the colon or rectum
* One or more measurable lesions
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2016
Sample size
Target
Accrual to date
Final
1254
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Ashford
Recruitment hospital [2] 0 0
Research Site - Camperdown
Recruitment hospital [3] 0 0
Research Site - Heidelberg
Recruitment hospital [4] 0 0
Research Site - Hornsby
Recruitment hospital [5] 0 0
Research Site - Liverpool
Recruitment hospital [6] 0 0
Research Site - Waratah
Recruitment hospital [7] 0 0
Research Site - Wodonga
Recruitment postcode(s) [1] 0 0
- Ashford
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Heidelberg
Recruitment postcode(s) [4] 0 0
- Hornsby
Recruitment postcode(s) [5] 0 0
- Liverpool
Recruitment postcode(s) [6] 0 0
- Waratah
Recruitment postcode(s) [7] 0 0
- Wodonga
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires City
Country [2] 0 0
Argentina
State/province [2] 0 0
Capital Federal
Country [3] 0 0
Argentina
State/province [3] 0 0
Ciudad de Buenos Aires
Country [4] 0 0
Argentina
State/province [4] 0 0
Córdoba
Country [5] 0 0
Argentina
State/province [5] 0 0
Resistencia
Country [6] 0 0
Argentina
State/province [6] 0 0
Rosario
Country [7] 0 0
Argentina
State/province [7] 0 0
Santa Fe
Country [8] 0 0
Brazil
State/province [8] 0 0
Curitiba
Country [9] 0 0
Brazil
State/province [9] 0 0
Goiânia
Country [10] 0 0
Brazil
State/province [10] 0 0
Jaú
Country [11] 0 0
Brazil
State/province [11] 0 0
Porto Alegre
Country [12] 0 0
Brazil
State/province [12] 0 0
Rio de Janeiro
Country [13] 0 0
Brazil
State/province [13] 0 0
Salvador
Country [14] 0 0
Brazil
State/province [14] 0 0
Santo André
Country [15] 0 0
Brazil
State/province [15] 0 0
Sao Paulo
Country [16] 0 0
Brazil
State/province [16] 0 0
São Paulo
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Plovdiv
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sofia
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Stara Zagora
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Varna
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Veliko Tarnovo
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Vratza
Country [23] 0 0
China
State/province [23] 0 0
Beijing
Country [24] 0 0
China
State/province [24] 0 0
Changchun
Country [25] 0 0
China
State/province [25] 0 0
Chengdu
Country [26] 0 0
China
State/province [26] 0 0
ChongQing
Country [27] 0 0
China
State/province [27] 0 0
Fuzhou
Country [28] 0 0
China
State/province [28] 0 0
Guangzhou
Country [29] 0 0
China
State/province [29] 0 0
Hangzhou
Country [30] 0 0
China
State/province [30] 0 0
Nanjing
Country [31] 0 0
China
State/province [31] 0 0
Nanning
Country [32] 0 0
China
State/province [32] 0 0
Shanghai
Country [33] 0 0
China
State/province [33] 0 0
Tianjin
Country [34] 0 0
Czech Republic
State/province [34] 0 0
Brno
Country [35] 0 0
Czech Republic
State/province [35] 0 0
Ceske Budejovice
Country [36] 0 0
Czech Republic
State/province [36] 0 0
Cheb
Country [37] 0 0
Czech Republic
State/province [37] 0 0
Jicin
Country [38] 0 0
Czech Republic
State/province [38] 0 0
Jihlava
Country [39] 0 0
Czech Republic
State/province [39] 0 0
Olomouc
Country [40] 0 0
Czech Republic
State/province [40] 0 0
Ostrava
Country [41] 0 0
Czech Republic
State/province [41] 0 0
Praha 6
Country [42] 0 0
Czech Republic
State/province [42] 0 0
Pribram - Zdabor
Country [43] 0 0
Czech Republic
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Sumperk
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Czech Republic
State/province [44] 0 0
Zlin
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Znojmo
Country [46] 0 0
Germany
State/province [46] 0 0
Essen
Country [47] 0 0
Germany
State/province [47] 0 0
Freiburg
Country [48] 0 0
Germany
State/province [48] 0 0
Goslar
Country [49] 0 0
Germany
State/province [49] 0 0
Hamburg
Country [50] 0 0
Germany
State/province [50] 0 0
Hildesheim
Country [51] 0 0
Germany
State/province [51] 0 0
Mannheim
Country [52] 0 0
Hungary
State/province [52] 0 0
Budapest
Country [53] 0 0
Hungary
State/province [53] 0 0
Debrecen
Country [54] 0 0
Hungary
State/province [54] 0 0
Györ
Country [55] 0 0
Hungary
State/province [55] 0 0
Kecskemét
Country [56] 0 0
Hungary
State/province [56] 0 0
Nyíregyháza
Country [57] 0 0
Hungary
State/province [57] 0 0
Szombathely
Country [58] 0 0
Hungary
State/province [58] 0 0
Zalaegerszeg
Country [59] 0 0
India
State/province [59] 0 0
Hyderabad
Country [60] 0 0
India
State/province [60] 0 0
Trivandrum
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Goyang-si
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Seoul
Country [63] 0 0
Philippines
State/province [63] 0 0
Cebu City
Country [64] 0 0
Philippines
State/province [64] 0 0
Davao City
Country [65] 0 0
Philippines
State/province [65] 0 0
Iloilo
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Philippines
State/province [66] 0 0
Quezon City
Country [67] 0 0
Philippines
State/province [67] 0 0
Quezon
Country [68] 0 0
Poland
State/province [68] 0 0
Bydgoszcz
Country [69] 0 0
Poland
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Gdansk
Country [70] 0 0
Poland
State/province [70] 0 0
Gliwice
Country [71] 0 0
Poland
State/province [71] 0 0
Kraków
Country [72] 0 0
Poland
State/province [72] 0 0
Olsztyn
Country [73] 0 0
Poland
State/province [73] 0 0
Torun
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Poland
State/province [74] 0 0
Wroclaw
Country [75] 0 0
Switzerland
State/province [75] 0 0
Bellinzona
Country [76] 0 0
Switzerland
State/province [76] 0 0
Lausanne
Country [77] 0 0
Switzerland
State/province [77] 0 0
Locarno
Country [78] 0 0
Switzerland
State/province [78] 0 0
Zürich
Country [79] 0 0
Taiwan
State/province [79] 0 0
Tainan
Country [80] 0 0
Taiwan
State/province [80] 0 0
Taipei
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Aberdeen
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Belfast
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Leicester
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00399035
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.
Public notes

Contacts
Principal investigator
Name 0 0
Jane Robertson
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00399035