Back to resultsFirst Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX (HORIZON III)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cediranib
Bevacizumab
5-fluorouracil ( in FOLFOX)
Leucovorin (in FOLFOX)
Oxaliplatin (in FOLFOX)
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Metastatic Colorectal Cancer, RECENTIN
Eligibility Criteria
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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Bevacizumab + FOLFOX
Cediranib + FOLFOX
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall Survival
Number of months from randomisation to the date of death from any cause
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.
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.
Percentage Change in Tumour Size
Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)*100
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00384176
Brief Title
First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX
Acronym
HORIZON III
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 30, 2006 (Actual)
Primary Completion Date
November 15, 2009 (Actual)
Study Completion Date
August 19, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Metastatic Colorectal Cancer, RECENTIN
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1814 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Bevacizumab + FOLFOX
Arm Title
2
Arm Type
Experimental
Arm Description
Cediranib + FOLFOX
Intervention Type
Drug
Intervention Name(s)
Cediranib
Other Intervention Name(s)
RECENTIN™, AZD2171
Intervention Description
oral tablet once daily
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin®
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil ( in FOLFOX)
Other Intervention Name(s)
5-FU
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Leucovorin (in FOLFOX)
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin (in FOLFOX)
Other Intervention Name(s)
Eloxatin®
Intervention Description
intravenous infusion
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
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.
Time Frame
Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Number of months from randomisation to the date of death from any cause
Time Frame
Randomisation until data cut-off
Title
Objective Response Rate
Description
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.
Time Frame
Up until data cut-off
Title
Duration of Response
Description
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.
Time Frame
Up until data cut-off date of 15/11/2007
Title
Percentage Change in Tumour Size
Description
Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)*100
Time Frame
Baseline to Week 8
Title
Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)
Description
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.
Time Frame
Baseline through to data cut-off
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Robertson
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
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Anniston
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Alabama
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United States
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Birmingham
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Alabama
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United States
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Casa Grande
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Port St. Lucie
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Quincy
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Rochester
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Coffs Harbour
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Hornsby
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Kogarah
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Port Macquarie
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Australia
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Randwick
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Australia
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St. Leonards
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Tamworth
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Waratah
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South Brisbane
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Ashford
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Bedford Park
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Woodville South
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South Australia
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Hobart
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Epping
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Victoria
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Ashford
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Hobart
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Australia
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Lismore
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Randwick
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Australia
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South Brisbane
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St. Leonards
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Australia
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Tamworth
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Australia
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Waratah
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Wodonga
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Woodville South
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Kundratstrasse 3
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Vienna
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Innsbruck
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Austria
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Kundratstrasse 3
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Austria
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Austria
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Belgium
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Belgium
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York
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Levis
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Nova Ves pod Plesi
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Pardubice
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Tabor
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Czech Republic
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Alexandria
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Egypt
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Cairo
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Egypt
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Helsinki
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Finland
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Tampere
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Finland
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Turku
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Finland
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Vaasa
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Finland
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Boulogne Cedex
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France
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La Roche S YON
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France
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Marseille Cedex 08
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France
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Nantes,
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France
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Nantes
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France
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Paris Cedex 15
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France
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Paris
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France
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Saint Gregoire
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France
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Dresden
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Germany
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Essen
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Germany
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Freiburg
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Germany
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Halle
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Munchen
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Germany
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München
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Germany
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Neu-isenburg
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Germany
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Tubingen
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Germany
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Tübingen
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Germany
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Budapest
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Hungary
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Debrecen
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Hungary
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Pecs
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Hungary
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Pécs
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Hungary
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Szeged
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Hungary
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Tatabanya
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Hungary
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Tatabánya
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Hungary
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Bhopal
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Madhya Pradesh
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India
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Pune
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India
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Jaipur
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Rajasthan
Country
India
Facility Name
Research Site
City
Varanasi
State/Province
Uttar Prad
Country
India
Facility Name
Research Site
City
Kolkata
State/Province
W Bengal
Country
India
Facility Name
Research Site
City
Bangalore
Country
India
Facility Name
Research Site
City
Bhopal
Country
India
Facility Name
Research Site
City
Chennai
Country
India
Facility Name
Research Site
City
Hyderabad
Country
India
Facility Name
Research Site
City
Jaipur
Country
India
Facility Name
Research Site
City
Kolkata
Country
India
Facility Name
Research Site
City
Mumbai
Country
India
Facility Name
Research Site
City
Pune
Country
India
Facility Name
Research Site
City
Sheikhpura
Country
India
Facility Name
Research Site
City
Holon
Country
Israel
Facility Name
Research Site
City
Kfar-saba
Country
Israel
Facility Name
Research Site
City
Petah Tikva
Country
Israel
Facility Name
Research Site
City
Tel Aviv
Country
Israel
Facility Name
Research Site
City
Tel-Hashomer
Country
Israel
Facility Name
Research Site
City
Tiberias
Country
Israel
Facility Name
Research Site
City
Tzrifin
Country
Israel
Facility Name
Research Site
City
Genova
State/Province
GE
Country
Italy
Facility Name
Research Site
City
Rozzano
State/Province
MI
Country
Italy
Facility Name
Research Site
City
Ancona
Country
Italy
Facility Name
Research Site
City
Genova
Country
Italy
Facility Name
Research Site
City
Napoli
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Rozzano
Country
Italy
Facility Name
Research Site
City
Riga
Country
Latvia
Facility Name
Research Site
City
Floriana
Country
Malta
Facility Name
Research Site
City
Valletta
Country
Malta
Facility Name
Research Site
City
Cebu City
Country
Philippines
Facility Name
Research Site
City
Davao City
Country
Philippines
Facility Name
Research Site
City
Molo
Country
Philippines
Facility Name
Research Site
City
Quezon City
Country
Philippines
Facility Name
Research Site
City
Bytom
Country
Poland
Facility Name
Research Site
City
Elblag
Country
Poland
Facility Name
Research Site
City
Gdynia
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Kraków
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Poznan
Country
Poland
Facility Name
Research Site
City
Poznań
Country
Poland
Facility Name
Research Site
City
Rybnik
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Barnaul
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
Country
Russian Federation
Facility Name
Research Site
City
Omsk
Country
Russian Federation
Facility Name
Research Site
City
Tomsk
Country
Russian Federation
Facility Name
Research Site
City
Tumen
Country
Russian Federation
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Kosice
Country
Slovakia
Facility Name
Research Site
City
Nitra
Country
Slovakia
Facility Name
Research Site
City
Presov
Country
Slovakia
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Lyttelton Manor
Country
South Africa
Facility Name
Research Site
City
Polokwane
Country
South Africa
Facility Name
Research Site
City
Port Elizabeth
Country
South Africa
Facility Name
Research Site
City
Pretoria
Country
South Africa
Facility Name
Research Site
City
Cordoba
State/Province
Andalucia
Country
Spain
Facility Name
Research Site
City
Zaragoza
State/Province
Aragon
Country
Spain
Facility Name
Research Site
City
Oviedo
State/Province
Asturias
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Granollers
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Hospitalet de Llobregat(barcel
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Terrassa(barcelona)
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Madrid
State/Province
Comunidad de Madrid
Country
Spain
Facility Name
Research Site
City
Valencia
State/Province
Comunidad Valenciana
Country
Spain
Facility Name
Research Site
City
A Coruna
State/Province
Galicia
Country
Spain
Facility Name
Research Site
City
A Coruña
Country
Spain
Facility Name
Research Site
City
Córdoba
Country
Spain
Facility Name
Research Site
City
Granollers
Country
Spain
Facility Name
Research Site
City
Hospitalet de Llobregat(Barcel
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Manresa
Country
Spain
Facility Name
Research Site
City
Oviedo
Country
Spain
Facility Name
Research Site
City
Valencia
Country
Spain
Facility Name
Research Site
City
Zaragoza
Country
Spain
Facility Name
Research Site
City
Tainan
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Tao-yuan
Country
Taiwan
Facility Name
Research Site
City
Nakhonratchasima
State/Province
Naimuang
Country
Thailand
Facility Name
Research Site
City
Chiang Mai
Country
Thailand
Facility Name
Research Site
City
Rachathewi
Country
Thailand
Facility Name
Research Site
City
Songkla
Country
Thailand
Facility Name
Research Site
City
Istanbul
State/Province
Goztepe
Country
Turkey
Facility Name
Research Site
City
Ankara
Country
Turkey
Facility Name
Research Site
City
Izmir
Country
Turkey
Facility Name
Research Site
City
Cherkassy
Country
Ukraine
Facility Name
Research Site
City
Chernigiv
Country
Ukraine
Facility Name
Research Site
City
Chernivtsi
Country
Ukraine
Facility Name
Research Site
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Research Site
City
Donetsk
Country
Ukraine
Facility Name
Research Site
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
Country
Ukraine
Facility Name
Research Site
City
Kharkov
Country
Ukraine
Facility Name
Research Site
City
Kherson
Country
Ukraine
Facility Name
Research Site
City
Kiev
Country
Ukraine
Facility Name
Research Site
City
Kyiv
Country
Ukraine
Facility Name
Research Site
City
Lugansk
Country
Ukraine
Facility Name
Research Site
City
Lviv
Country
Ukraine
Facility Name
Research Site
City
Poltava
Country
Ukraine
Facility Name
Research Site
City
Simferopol
Country
Ukraine
Facility Name
Research Site
City
Sumy
Country
Ukraine
Facility Name
Research Site
City
Ternopil
Country
Ukraine
Facility Name
Research Site
City
Ternopol
Country
Ukraine
Facility Name
Research Site
City
Uzhgorod
Country
Ukraine
Facility Name
Research Site
City
Southampton
State/Province
Hampshire
Country
United Kingdom
Facility Name
Research Site
City
Maidstone
State/Province
Kent
Country
United Kingdom
Facility Name
Research Site
City
Northwood
State/Province
Middlesex
Country
United Kingdom
Facility Name
Research Site
City
Sutton
State/Province
Surrey
Country
United Kingdom
Facility Name
Research Site
City
Bebington
Country
United Kingdom
Facility Name
Research Site
City
Bournemouth
Country
United Kingdom
Facility Name
Research Site
City
Bradford
Country
United Kingdom
Facility Name
Research Site
City
Guildford
Country
United Kingdom
Facility Name
Research Site
City
Ipswich
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Maidstone
Country
United Kingdom
Facility Name
Research Site
City
Newcastle Upon Tyne
Country
United Kingdom
Facility Name
Research Site
City
Newcastle-upon-tyne
Country
United Kingdom
Facility Name
Research Site
City
Northwood
Country
United Kingdom
Facility Name
Research Site
City
Poole
Country
United Kingdom
Facility Name
Research Site
City
Stockport
Country
United Kingdom
Facility Name
Research Site
City
Sutton
Country
United Kingdom
Facility Name
Research Site
City
Hanoi city
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh city
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
Country
Vietnam
12. IPD Sharing Statement
Citations:
PubMed Identifier
31378656
Citation
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.
Results Reference
derived
PubMed Identifier
30679026
Citation
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.
Results Reference
derived
PubMed Identifier
19203899
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=417&filename=CSR-D8480C00013.pdf
Description
CSR-D8480C00013.pdf
Learn more about this trial
First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX
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