Colorectal CancerPhase 2/3HORIZON IIINCT00384176

First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX

A Phase 2/3 study testing Cediranib, Bevacizumab and 5-fluorouracil ( in FOLFOX) in people with Colorectal Cancer, run by AstraZeneca at 280 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX. Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Colorectal Cancer
What is being tested?: Cediranib, Bevacizumab and 5-fluorouracil ( in FOLFOX)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,814 participants
Where: 280 sitesin 28 countries
Study dates: 30 Aug 2006to 19 Aug 2015
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical Diagnosis of colon or rectal cancer
No prior systemic therapy for metastatic disease. Any adjuvant/neoadjuvant oxaliplatin therapy must have been received >12 months prior to study entry and adjuvant/neoadjuvant 5-FU must have been received >6 months prior to study entry.

Who cannot join

Prior treatment with a VEGF Inhibitor, including bevacizumab and cediranib.
Poorly controlled hypertension

Trial locations and contacts

280 sites in 28 countries.

Country

City, postcode or hospital

280 sites in 28 countries

United States44 sites

Research Site
Abingdon, Virginia
Research Site
Alexandria, Louisiana
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Alexandria, Virginia
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Ann Arbor, Michigan
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Anniston, Alabama
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Austin, Texas
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Bay Pines, Florida
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Birmingham, Alabama
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Bismarck, North Dakota
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Casa Grande, Arizona
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Chattanooga, Tennessee
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Cincinnati, Ohio
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Coos Bay, Oregon
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Fairfield, Connecticut
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Fayetteville, North Carolina
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Fort Meyers, Florida
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Fresh Meadows, New York
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Galesburg, Illinois
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Great Falls, Montana
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Hagerstown, Maryland
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Hilton Head Island, South Carolina
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Hot Springs, Arkansas
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Knoxville, Tennessee
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Layfayette, Indiana
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Layfayette, Louisiana
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Lincoln, Nebraska
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Middletown, Ohio
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Nashville, Tennessee
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New Albany, Indiana
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New Bern, North Carolina
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Northport, New York
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Palm Springs, California
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Park Ridge, Illinois
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Port Saint Lucie, Florida
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Quincy, Illinois
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Rochester, New York
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San Diego, California
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St Louis, Missouri
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Stamford, Connecticut
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Summit, New Jersey
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Tucson, Arizona
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White River Junction, Vermont
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Ypsilanti, Michigan
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Zanesville, Ohio

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Australia40 sites

Research Site
Armidale, New South Wales
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Ashford, South Australia
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Ashford
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Bedford Park, South Australia
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Bedford Park
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Bendigo
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Box Hill
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Camperdown
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Coffs Harbour, New South Wales
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Coffs Harbour
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Darlinghurst, New South Wales
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Darlinghurst
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East Melbourne
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Epping, Victoria
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Epping
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Herston
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Hobart, Tasmania
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Hobart
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Hornsby, New South Wales
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Hornsby
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Kogarah, New South Wales
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Kogarah
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Lismore
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Malvern
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Nedlands
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Port Macquarie, New South Wales
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Port Macquarie
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Randwick, New South Wales
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Randwick
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South Brisbane, Queensland
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South Brisbane
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St Leonards, New South Wales
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St Leonards
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Tamworth, New South Wales
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Tamworth
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Waratah, New South Wales
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Waratah
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Wodonga
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Woodville South, South Australia
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Woodville South

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Spain19 sites

Research Site
A Coruña, Galicia
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A Coruña
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Barcelona, Catalonia
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Córdoba, Andalusia
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Córdoba
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Granollers, Catalonia
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Granollers
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Hospitalet de Llobregat(barcel, Catalonia
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Hospitalet de Llobregat(Barcel
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Madrid, Madrid
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Madrid
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Manresa
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Oviedo, Principality of Asturias
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Oviedo
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Terrassa(barcelona), Catalonia
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Valencia, Valencia
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Valencia
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Zaragoza, Aragon
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Zaragoza

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Ukraine17 sites

Research Site
Cherkassy
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Chernihiv
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Chernivtsi
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Dnipropetrovsk
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Donetsk
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Ivano-Frankivsk
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Kharkiv
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Kherson
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Kiev
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Kyiv
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Luhansk
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Lviv
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Poltava
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Simferopol
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Sumy
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Ternopil
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Uzhhorod

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Canada16 sites

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Barrie, Ontario
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Calgary, Alberta
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Edmonton, Alberta
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Greater Sudbury, Ontario
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Lévis, Quebec
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Montreal, Quebec
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Montreal
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Newmarket, Ontario
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Québec, Quebec
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Scarborough Village, Ontario
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St. Catharines, Ontario
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Surrey, British Columbia
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Sydney, Nova Scotia
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Toronto, Ontario
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Vancouver, British Columbia
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York, Ontario

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United Kingdom16 sites

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Bebington
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Bournemouth
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Bradford
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Guildford
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Ipswich
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London
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Maidstone, Kent
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Maidstone
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Newcastle upon Tyne
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Northwood, Middlesex
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Northwood
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Poole
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Southampton, Hampshire
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Stockport
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Sutton, Surrey
Research Site
Sutton

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Belgium15 sites

Research Site
Bonheiden, Belgium
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Bonheiden
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Bruges
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Brussels (woluwe-st-lambert), Belgium
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Brussels (Woluwé-St-Lambert)
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Edegem, Belgium
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Edegem
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Ghent, Belgium
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Ghent
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Kortrijk, Belgium
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Kortrijk
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Leuven, Belgium
Research Site
Leuven
Research Site
Roeselare, Belgium
Research Site
Roeselare

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India14 sites

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Bangalore
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Bhopal, Madhya Pradesh
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Bhopal
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Chennai
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Hyderabad
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Jaipur, Rajasthan
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Jaipur
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Kolkata, West Bengal
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Kolkata
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Mumbai
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Pune, Maharashtra
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Pune
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Sheikhpura
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Varanasi, Uttar Prad

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Germany9 sites

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Dresden
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Essen
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Freiburg im Breisgau
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Halle
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Hanover
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Heidelberg
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München
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Neu-Isenburg
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Tübingen

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Italy8 sites

Research Site
Ancona
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Genova, GE
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Genova
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Naples
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Roma, Roma
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Roma
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Rozzano, MI
Research Site
Rozzano

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Poland8 sites

Research Site
Bytom
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Elblag
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Gdynia
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Krakow
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Lublin
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Poznan
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Rybnik
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Warsaw

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Austria7 sites

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Innsbruck
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Kundratstrasse 3, State of Vienna
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Kundratstrasse 3
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Salzburg
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Vienna
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Wels
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Zams

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Israel7 sites

Research Site
Holon
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Kfar Saba
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Petah Tikva
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Tel Aviv
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Tel HaShomer
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Tiberias
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Tzrifin

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Czechia6 sites

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Brno
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Chomutov
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Kutná Hora
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Nová Ves pod Pleší
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Pardubice
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Tábor

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France6 sites

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Boulogne
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La Roche S YON
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Marseille
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Nantes
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Paris
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Saint-Grégoire

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Thailand6 sites

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Chiang Mai, Thailand
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Chiang Mai
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Nakhonratchasima, Naimuang
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Rachathewi
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Songkhla, Thailand
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Songkhla

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Hungary5 sites

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Budapest
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Debrecen
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Pécs
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Szeged
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Tatabánya

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Russia5 sites

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Barnaul
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Novosibirsk
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Omsk
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Tomsk
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Tyumen

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South Africa5 sites

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Cape Town
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Lyttelton Manor, South Africa
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Polokwane
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Port Elizabeth
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Pretoria

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Finland4 sites

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Helsinki
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Tampere
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Turku
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Vaasa

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Philippines4 sites

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Cebu City
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Davao City
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Molo
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Quezon City

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Slovakia4 sites

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Bratislava
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Košice
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Nitra
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Prešov

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Vietnam4 sites

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Hanoi, Vietnam
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Hanoi
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City

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Taiwan3 sites

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Tainan
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Taipei
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Taoyuan, Taiwan

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Turkey (Türkiye)3 sites

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Ankara
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Istanbul, Goztepe
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Izmir

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Egypt2 sites

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Alexandria
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Cairo

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Malta2 sites

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Valletta

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Latvia1 site

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Riga

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About this study

Official title: A Randomised, Double-blind, Multicentre Phase II/III Study to Compare the Efficacy of Cediranib (RECENTIN™, AZD2171) in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX), to the Efficacy of Bevacizumab in Combination With FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer

Conditions: Colorectal Cancer
Being tested: Cediranib, Bevacizumab, 5-fluorouracil ( in FOLFOX), Leucovorin (in FOLFOX), Oxaliplatin (in FOLFOX)
Keywords: Metastatic Colorectal Cancer, RECENTIN
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CediranibDrug
Also called RECENTIN™, AZD2171
oral tablet once daily
BevacizumabDrug
Also called Avastin®
intravenous infusion
5-fluorouracil ( in FOLFOX)Drug
Also called 5-FU
intravenous infusion
Leucovorin (in FOLFOX)Drug
intravenous infusion
Oxaliplatin (in FOLFOX)Drug
Also called Eloxatin®
intravenous infusion

Study groups in NCT00384176
Study group	Role	What they receive
1	Active comparator	Bevacizumab + FOLFOX Receives: Drug: Bevacizumab; Drug: 5-fluorouracil ( in FOLFOX); Drug: Leucovorin (in FOLFOX); Drug: Oxaliplatin (in FOLFOX)
2	Experimental	Cediranib + FOLFOX Receives: Drug: Cediranib; Drug: 5-fluorouracil ( in FOLFOX); Drug: Leucovorin (in FOLFOX); Drug: Oxaliplatin (in FOLFOX)

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival
Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
Measured: Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression

Secondary outcomes (5)

Overall Survival
Number of months from randomisation to the date of death from any cause
Measured: Randomisation until data cut-off
Objective Response Rate
Objective response rate is Complete Response (CR) + Partial Response (PR) as defined below:
CR = Disappearance of all target lesions. PR = At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs.
Measured: Up until data cut-off
Duration of Response
Duration of Response is calculated as the time from the first recording of CR/PR until the patient progresses, regardless of whether the patient was still taking study medication. Only confirmed responses are included in the calculation. For patients who had not progressed, the end date used in the calculation of duration of response is the data cut-off date of 15th November 2009.
Measured: Up until data cut-off date of 15/11/2007
Percentage Change in Tumour Size
Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)*100
Measured: Baseline to Week 8
Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)
Time to worsening of symptoms, as measured by the FACT colorectal symptom index (FCSI), will be defined as the time when a sustained clinically important deterioration in the total score from the FCSI has been recorded.
Measured: Baseline through to data cut-off

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 200619 Aug 2015

First posted5 Oct 2006 (estimated)
Study start30 Aug 2006
Primary completion15 Nov 2009
Study completion19 Aug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,814 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00384176
Sponsor's protocol ID: D8480C00013
Other IDs: Eudract Number 2005-003440-66
Acronym: HORIZON III
Status last verified: Apr 2017
First submitted: 3 Oct 2006
Last updated: 14 Apr 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

Abdel-Rahman O. Effect of Body Mass Index on 5-FU-Based Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer; A Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Dec;18(4):e385-e393. doi: 10.1016/j.clcc.2019.07.005. Epub 2019 Jul 15.
PubMed 31378656
Abdel-Rahman O. Impact of Sex on Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer: Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Jun;18(2):110-115.e2. doi: 10.1016/j.clcc.2018.12.006. Epub 2018 Dec 28.
PubMed 30679026
Robertson JD, Botwood NA, Rothenberg ML, Schmoll HJ. Phase III trial of FOLFOX plus bevacizumab or cediranib (AZD2171) as first-line treatment of patients with metastatic colorectal cancer: HORIZON III. Clin Colorectal Cancer. 2009 Jan;8(1):59-60. doi: 10.3816/CCC.2009.n.010.
PubMed 19203899

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Multicentre Phase II/III Study to Compare the Efficacy of Cediranib (RECENTIN™, AZD2171) in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX), to the Efficacy of Bevacizumab in Combination With FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT00384176
Acronym / sponsor ID: HORIZON III / D8480C00013
Conditions: Colorectal Cancer
Keywords: Metastatic Colorectal Cancer, RECENTIN
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,814 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 30 Aug 2006 (actual)
Primary completion: 15 Nov 2009 (actual)
Study completion: 19 Aug 2015 (actual)
First posted: 5 Oct 2006 (estimated)
Results: Posted 28 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: Bevacizumab, Drug: 5-fluorouracil ( in FOLFOX), Drug: Leucovorin (in FOLFOX), Drug: Oxaliplatin (in FOLFOX)Bevacizumab + FOLFOX
2	Experimental	Drug: Cediranib, Drug: 5-fluorouracil ( in FOLFOX), Drug: Leucovorin (in FOLFOX), Drug: Oxaliplatin (in FOLFOX)Cediranib + FOLFOX

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Clinical Diagnosis of colon or rectal cancer
No prior systemic therapy for metastatic disease. Any adjuvant/neoadjuvant oxaliplatin therapy must have been received >12 months prior to study entry and adjuvant/neoadjuvant 5-FU must have been received >6 months prior to study entry.

Key exclusion criteria (2 listed)

Prior treatment with a VEGF Inhibitor, including bevacizumab and cediranib.
Poorly controlled hypertension

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CediranibAlso: RECENTIN™, AZD2171oral tablet once daily	Drug	2
BevacizumabAlso: Avastin®intravenous infusion	Drug	1
5-fluorouracil ( in FOLFOX)Also: 5-FUintravenous infusion	Drug	1, 2
Leucovorin (in FOLFOX)intravenous infusion	Drug	1, 2
Oxaliplatin (in FOLFOX)Also: Eloxatin®intravenous infusion	Drug	1, 2

Primary outcome

Progression Free Survival
Time frame: Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression
Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.

5 secondary outcomes

Overall Survival
Time frame: Randomisation until data cut-off
Objective Response Rate
Time frame: Up until data cut-off
Duration of Response
Time frame: Up until data cut-off date of 15/11/2007
Percentage Change in Tumour Size
Time frame: Baseline to Week 8
Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)
Time frame: Baseline through to data cut-off

Results and safety

Results posted to the registry on 28 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cediranib 20 mg	709	397
Bevacizumab 5 mg/kg	713	394
Cediranib 30 mg	192	60

Primary outcome: Progression Free Survival

Time frame: Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression. Median (Inter-Quartile Range). Unit: Months

Measure	Cediranib 20 mg n = 709	Bevacizumab 5 mg/kg n = 713	Cediranib 30 mg n = 0
Value	9.9 (6.3 to 13.5)	10.3 (6.5 to 14.1)	–

Population analysed: Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cediranib 20 mg	275 of 705 (39%)	684 of 705 (97%)	Not reported
Cediranib 30 mg	90 of 191 (47.1%)	187 of 191 (97.9%)	Not reported
1Bevacizumab 5mg/kg	231 of 704 (32.8%)	672 of 704 (95.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31378656Abdel-Rahman O. Effect of Body Mass Index on 5-FU-Based Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer; A Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Dec;18(4):e385-e393. doi: 10.1016/j.clcc.2019.07.005. Epub 2019 Jul 15.
Derived from this study: PubMed 30679026Abdel-Rahman O. Impact of Sex on Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer: Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Jun;18(2):110-115.e2. doi: 10.1016/j.clcc.2018.12.006. Epub 2018 Dec 28.
Derived from this study: PubMed 19203899Robertson JD, Botwood NA, Rothenberg ML, Schmoll HJ. Phase III trial of FOLFOX plus bevacizumab or cediranib (AZD2171) as first-line treatment of patients with metastatic colorectal cancer: HORIZON III. Clin Colorectal Cancer. 2009 Jan;8(1):59-60. doi: 10.3816/CCC.2009.n.010.
CSR-D8480C00013.pdfLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jane Robertson study director

AstraZeneca

280 sites in 28 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cediranib, Bevacizumab and 5-fluorouracil ( in FOLFOX) in people with Colorectal Cancer, run by AstraZeneca at 280 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 280 sites in United States, Australia, Spain, Ukraine, Canada and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00384176, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.