First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX (HORIZON III)

April 13, 2017 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1814

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Ashford, Australia
        • Research Site
      • Bedford Park, Australia
        • Research Site
      • Bendigo, Australia
        • Research Site
      • Box Hill, Australia
        • Research Site
      • Camperdown, Australia
        • Research Site
      • Coffs Harbour, Australia
        • Research Site
      • Darlinghurst, Australia
        • Research Site
      • East-Melbourne, Australia
        • Research Site
      • Epping, Australia
        • Research Site
      • Herston, Australia
        • Research Site
      • Hobart, Australia
        • Research Site
      • Hornsby, Australia
        • Research Site
      • Kogarah, Australia
        • Research Site
      • Lismore, Australia
        • Research Site
      • Malvern, Australia
        • Research Site
      • Nedlands, Australia
        • Research Site
      • Port Macquarie, Australia
        • Research Site
      • Randwick, Australia
        • Research Site
      • South Brisbane, Australia
        • Research Site
      • St. Leonards, Australia
        • Research Site
      • Tamworth, Australia
        • Research Site
      • Waratah, Australia
        • Research Site
      • Wodonga, Australia
        • Research Site
      • Woodville South, Australia
        • Research Site
    • New South Wales
      • Armidale, New South Wales, Australia
        • Research Site
      • Coffs Harbour, New South Wales, Australia
        • Research Site
      • Darlinghurst, New South Wales, Australia
        • Research Site
      • Hornsby, New South Wales, Australia
        • Research Site
      • Kogarah, New South Wales, Australia
        • Research Site
      • Port Macquarie, New South Wales, Australia
        • Research Site
      • Randwick, New South Wales, Australia
        • Research Site
      • St. Leonards, New South Wales, Australia
        • Research Site
      • Tamworth, New South Wales, Australia
        • Research Site
      • Waratah, New South Wales, Australia
        • Research Site
    • Queensland
      • South Brisbane, Queensland, Australia
        • Research Site
    • South Australia
      • Ashford, South Australia, Australia
        • Research Site
      • Bedford Park, South Australia, Australia
        • Research Site
      • Woodville South, South Australia, Australia
        • Research Site
    • Tasmania
      • Hobart, Tasmania, Australia
        • Research Site
    • Victoria
      • Epping, Victoria, Australia
        • Research Site
  • Austria
      • Innsbruck, Austria
        • Research Site
      • Kundratstrasse 3, Austria
        • Research Site
      • Salzburg, Austria
        • Research Site
      • Wels, Austria
        • Research Site
      • Wien, Austria
        • Research Site
      • Zams, Austria
        • Research Site
    • Vienna
      • Kundratstrasse 3, Vienna, Austria
        • Research Site
  • Belgium
      • Bonheiden, Belgium
        • Research Site
      • Brugge, Belgium
        • Research Site
      • Brussels (Woluwé-St-Lambert), Belgium
        • Research Site
      • Brussels (woluwe-st-lambert), Belgium
        • Research Site
      • Edegem, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Ghent, Belgium
        • Research Site
      • Kortrijk, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
      • Roeselare, Belgium
        • Research Site
  • Canada
      • Montreal, Canada
        • Research Site
      • Quebec, Canada
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Surrey, British Columbia, Canada
        • Research Site
      • Vancouver, British Columbia, Canada
        • Research Site
    • Nova Scotia
      • Sydney, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Barrie, Ontario, Canada
        • Research Site
      • Newmarket, Ontario, Canada
        • Research Site
      • Scarborough, Ontario, Canada
        • Research Site
      • St Catharines, Ontario, Canada
        • Research Site
      • Sudbury, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
      • York, Ontario, Canada
        • Research Site
    • Quebec
      • Levis, Quebec, Canada
        • Research Site
      • Montreal, Quebec, Canada
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Chomutov, Czech Republic
        • Research Site
      • Kutna Hora, Czech Republic
        • Research Site
      • Nova Ves pod Plesi, Czech Republic
        • Research Site
      • Pardubice, Czech Republic
        • Research Site
      • Tabor, Czech Republic
        • Research Site
  • Egypt
      • Alexandria, Egypt
        • Research Site
      • Cairo, Egypt
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
      • Turku, Finland
        • Research Site
      • Vaasa, Finland
        • Research Site
  • France
      • Boulogne Cedex, France
        • Research Site
      • La Roche S YON, France
        • Research Site
      • Marseille Cedex 08, France
        • Research Site
      • Nantes, France
        • Research Site
      • Nantes,, France
        • Research Site
      • Paris, France
        • Research Site
      • Paris Cedex 15, France
        • Research Site
      • Saint Gregoire, France
        • Research Site
  • Germany
      • Dresden, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Freiburg, Germany
        • Research Site
      • Halle, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • München, Germany
        • Research Site
      • Neu-isenburg, Germany
        • Research Site
      • Tubingen, Germany
        • Research Site
      • Tübingen, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Pecs, Hungary
        • Research Site
      • Pécs, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
      • Tatabanya, Hungary
        • Research Site
      • Tatabánya, Hungary
        • Research Site
  • India
      • Bangalore, India
        • Research Site
      • Bhopal, India
        • Research Site
      • Chennai, India
        • Research Site
      • Hyderabad, India
        • Research Site
      • Jaipur, India
        • Research Site
      • Kolkata, India
        • Research Site
      • Mumbai, India
        • Research Site
      • Pune, India
        • Research Site
      • Sheikhpura, India
        • Research Site
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, India
        • Research Site
    • Maharashtra
      • Pune, Maharashtra, India
        • Research Site
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Research Site
    • Uttar Prad
      • Varanasi, Uttar Prad, India
        • Research Site
    • W Bengal
      • Kolkata, W Bengal, India
        • Research Site
  • Israel
      • Holon, Israel
        • Research Site
      • Kfar-saba, Israel
        • Research Site
      • Petah Tikva, Israel
        • Research Site
      • Tel Aviv, Israel
        • Research Site
      • Tel-Hashomer, Israel
        • Research Site
      • Tiberias, Israel
        • Research Site
      • Tzrifin, Israel
        • Research Site
  • Italy
      • Ancona, Italy
        • Research Site
      • Genova, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • Rozzano, Italy
        • Research Site
    • GE
      • Genova, GE, Italy
        • Research Site
    • MI
      • Rozzano, MI, Italy
        • Research Site
  • Latvia
      • Riga, Latvia
        • Research Site
  • Malta
      • Floriana, Malta
        • Research Site
      • Valletta, Malta
        • Research Site
  • Philippines
      • Cebu City, Philippines
        • Research Site
      • Davao City, Philippines
        • Research Site
      • Molo, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
  • Poland
      • Bytom, Poland
        • Research Site
      • Elblag, Poland
        • Research Site
      • Gdynia, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Kraków, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Poznań, Poland
        • Research Site
      • Rybnik, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
  • Russian Federation
      • Barnaul, Russian Federation
        • Research Site
      • Novosibirsk, Russian Federation
        • Research Site
      • Omsk, Russian Federation
        • Research Site
      • Tomsk, Russian Federation
        • Research Site
      • Tumen, Russian Federation
        • Research Site
  • Slovakia
      • Bratislava, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Nitra, Slovakia
        • Research Site
      • Presov, Slovakia
        • Research Site
  • South Africa
      • Cape Town, South Africa
        • Research Site
      • Lyttelton Manor, South Africa
        • Research Site
      • Polokwane, South Africa
        • Research Site
      • Port Elizabeth, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
  • Spain
      • A Coruña, Spain
        • Research Site
      • Córdoba, Spain
        • Research Site
      • Granollers, Spain
        • Research Site
      • Hospitalet de Llobregat(Barcel, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Manresa, Spain
        • Research Site
      • Oviedo, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
    • Andalucia
      • Cordoba, Andalucia, Spain
        • Research Site
    • Aragon
      • Zaragoza, Aragon, Spain
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spain
        • Research Site
    • Cataluna
      • Barcelona, Cataluna, Spain
        • Research Site
      • Granollers, Cataluna, Spain
        • Research Site
      • Hospitalet de Llobregat(barcel, Cataluna, Spain
        • Research Site
      • Terrassa(barcelona), Cataluna, Spain
        • Research Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain
        • Research Site
    • Comunidad de Madrid
      • Madrid, Comunidad de Madrid, Spain
        • Research Site
    • Galicia
      • A Coruna, Galicia, Spain
        • Research Site
  • Taiwan
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Tao-yuan, Taiwan
        • Research Site
  • Thailand
      • Chiang Mai, Thailand
        • Research Site
      • Rachathewi, Thailand
        • Research Site
      • Songkla, Thailand
        • Research Site
    • Naimuang
      • Nakhonratchasima, Naimuang, Thailand
        • Research Site
  • Turkey
      • Ankara, Turkey
        • Research Site
      • Izmir, Turkey
        • Research Site
    • Goztepe
      • Istanbul, Goztepe, Turkey
        • Research Site
  • Ukraine
      • Cherkassy, Ukraine
        • Research Site
      • Chernigiv, Ukraine
        • Research Site
      • Chernivtsi, Ukraine
        • Research Site
      • Dnipropetrovsk, Ukraine
        • Research Site
      • Donetsk, Ukraine
        • Research Site
      • Ivano-Frankivsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kharkov, Ukraine
        • Research Site
      • Kherson, Ukraine
        • Research Site
      • Kiev, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Lugansk, Ukraine
        • Research Site
      • Lviv, Ukraine
        • Research Site
      • Poltava, Ukraine
        • Research Site
      • Simferopol, Ukraine
        • Research Site
      • Sumy, Ukraine
        • Research Site
      • Ternopil, Ukraine
        • Research Site
      • Ternopol, Ukraine
        • Research Site
      • Uzhgorod, Ukraine
        • Research Site
  • United Kingdom
      • Bebington, United Kingdom
        • Research Site
      • Bournemouth, United Kingdom
        • Research Site
      • Bradford, United Kingdom
        • Research Site
      • Guildford, United Kingdom
        • Research Site
      • Ipswich, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Maidstone, United Kingdom
        • Research Site
      • Newcastle Upon Tyne, United Kingdom
        • Research Site
      • Newcastle-upon-tyne, United Kingdom
        • Research Site
      • Northwood, United Kingdom
        • Research Site
      • Poole, United Kingdom
        • Research Site
      • Stockport, United Kingdom
        • Research Site
      • Sutton, United Kingdom
        • Research Site
    • Hampshire
      • Southampton, Hampshire, United Kingdom
        • Research Site
    • Kent
      • Maidstone, Kent, United Kingdom
        • Research Site
    • Middlesex
      • Northwood, Middlesex, United Kingdom
        • Research Site
    • Surrey
      • Sutton, Surrey, United Kingdom
        • Research Site
  • United States
    • Alabama
      • Anniston, Alabama, United States
        • Research Site
      • Birmingham, Alabama, United States
        • Research Site
    • Arizona
      • Casa Grande, Arizona, United States
        • Research Site
      • Tucson, Arizona, United States
        • Research Site
    • Arkansas
      • Hot Springs, Arkansas, United States
        • Research Site
    • California
      • Palm Springs, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
    • Connecticut
      • Fairfield, Connecticut, United States
        • Research Site
      • Stamford, Connecticut, United States
        • Research Site
    • Florida
      • Bay Pines, Florida, United States
        • Research Site
      • Fort Meyers, Florida, United States
        • Research Site
      • Port St Lucie, Florida, United States
        • Research Site
      • Port St. Lucie, Florida, United States
        • Research Site
    • Illinois
      • Galesburg, Illinois, United States
        • Research Site
      • Park Ridge, Illinois, United States
        • Research Site
      • Quincy, Illinois, United States
        • Research Site
    • Indiana
      • Layfayette, Indiana, United States
        • Research Site
      • New Albany, Indiana, United States
        • Research Site
    • Louisiana
      • Alexandria, Louisiana, United States
        • Research Site
      • Layfayette, Louisiana, United States
        • Research Site
    • Maryland
      • Hagerstown, Maryland, United States
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • Research Site
      • Ypsilanti, Michigan, United States
        • Research Site
    • Missouri
      • St Louis, Missouri, United States
        • Research Site
    • Montana
      • Great Falls, Montana, United States
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States
        • Research Site
    • New Jersey
      • Summit, New Jersey, United States
        • Research Site
    • New York
      • Fresh Meadows, New York, United States
        • Research Site
      • Northport, New York, United States
        • Research Site
      • Rochester, New York, United States
        • Research Site
    • North Carolina
      • Fayetteville, North Carolina, United States
        • Research Site
      • New Bern, North Carolina, United States
        • Research Site
    • North Dakota
      • Bismarck, North Dakota, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Middletown, Ohio, United States
        • Research Site
      • Zanesville, Ohio, United States
        • Research Site
    • Oregon
      • Coos Bay, Oregon, United States
        • Research Site
    • South Carolina
      • Hilton Head Island, South Carolina, United States
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Research Site
      • Knoxville, Tennessee, United States
        • Research Site
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
    • Vermont
      • White River Junction, Vermont, United States
        • Research Site
    • Virginia
      • Abingdon, Virginia, United States
        • Research Site
      • Alexandria, Virginia, United States
        • Research Site
  • Vietnam
      • Hanoi city, Vietnam
        • Research Site
      • Ho Chi Minh, Vietnam
        • Research Site
      • Ho Chi Minh city, Vietnam
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Bevacizumab + FOLFOX
Drug: Bevacizumab
intravenous infusion
Other Names:
  • Avastin®
Drug: 5-fluorouracil ( in FOLFOX)
intravenous infusion
Other Names:
  • 5-FU
Drug: Leucovorin (in FOLFOX)
intravenous infusion
Drug: Oxaliplatin (in FOLFOX)
intravenous infusion
Other Names:
  • Eloxatin®
Experimental: 2
Cediranib + FOLFOX
Drug: 5-fluorouracil ( in FOLFOX)
intravenous infusion
Other Names:
  • 5-FU
Drug: Leucovorin (in FOLFOX)
intravenous infusion
Drug: Oxaliplatin (in FOLFOX)
intravenous infusion
Other Names:
  • Eloxatin®
Drug: Cediranib
oral tablet once daily
Other Names:
  • RECENTIN™
  • AZD2171

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Randomisation until data cut-off
Number of months from randomisation to the date of death from any cause
Randomisation until data cut-off
Objective Response Rate
Time Frame: Up until data cut-off

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.
Up until data cut-off
Duration of Response
Time Frame: Up until data cut-off date of 15/11/2007
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.
Up until data cut-off date of 15/11/2007
Percentage Change in Tumour Size
Time Frame: Baseline to Week 8
Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)*100
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
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.
Baseline through to data cut-off

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2006

Primary Completion (Actual)

November 15, 2009

Study Completion (Actual)

August 19, 2015

Study Registration Dates

First Submitted

October 3, 2006

First Submitted That Met QC Criteria

October 3, 2006

First Posted (Estimate)

October 5, 2006

Study Record Updates

Last Update Posted (Actual)

April 14, 2017

Last Update Submitted That Met QC Criteria

April 13, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8480C00013
  • Eudract Number 2005-003440-66

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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