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

Other trials in United States

Australia40 sites

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

Other trials in Australia

Spain19 sites

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

Other trials in Spain

Ukraine17 sites

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

Other trials in Ukraine

Canada16 sites

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

Other trials in Canada

United Kingdom16 sites

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

Other trials in United Kingdom

Belgium15 sites

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

Other trials in Belgium

India14 sites

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

Other trials in India

Germany9 sites

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

Other trials in Germany

Italy8 sites

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

Other trials in Italy

Poland8 sites

Research Site
Bytom
Research Site
Elblag
Research Site
Gdynia
Research Site
Krakow
Research Site
Lublin
Research Site
Poznan
Research Site
Rybnik
Research Site
Warsaw

Other trials in Poland

Austria7 sites

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

Other trials in Austria

Israel7 sites

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

Other trials in Israel

Czechia6 sites

Research Site
Brno
Research Site
Chomutov
Research Site
Kutná Hora
Research Site
Nová Ves pod Pleší
Research Site
Pardubice
Research Site
Tábor

Other trials in Czechia

France6 sites

Research Site
Boulogne
Research Site
La Roche S YON
Research Site
Marseille
Research Site
Nantes
Research Site
Paris
Research Site
Saint-Grégoire

Other trials in France

Thailand6 sites

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

Other trials in Thailand

Hungary5 sites

Research Site
Budapest
Research Site
Debrecen
Research Site
Pécs
Research Site
Szeged
Research Site
Tatabánya

Other trials in Hungary

Russia5 sites

Research Site
Barnaul
Research Site
Novosibirsk
Research Site
Omsk
Research Site
Tomsk
Research Site
Tyumen

Other trials in Russia

South Africa5 sites

Research Site
Cape Town
Research Site
Lyttelton Manor, South Africa
Research Site
Polokwane
Research Site
Port Elizabeth
Research Site
Pretoria

Other trials in South Africa

Finland4 sites

Research Site
Helsinki
Research Site
Tampere
Research Site
Turku
Research Site
Vaasa

Other trials in Finland

Philippines4 sites

Research Site
Cebu City
Research Site
Davao City
Research Site
Molo
Research Site
Quezon City

Other trials in Philippines

Slovakia4 sites

Research Site
Bratislava
Research Site
Košice
Research Site
Nitra
Research Site
Prešov

Other trials in Slovakia

Vietnam4 sites

Research Site
Hanoi, Vietnam
Research Site
Hanoi
Research Site
Ho Chi Minh City, Vietnam
Research Site
Ho Chi Minh City

Other trials in Vietnam

Taiwan3 sites

Research Site
Tainan
Research Site
Taipei
Research Site
Taoyuan, Taiwan

Other trials in Taiwan

Turkey (Türkiye)3 sites

Research Site
Ankara
Research Site
Istanbul, Goztepe
Research Site
Izmir

Other trials in Turkey (Türkiye)

Egypt2 sites

Research Site
Alexandria
Research Site
Cairo

Other trials in Egypt

Malta2 sites

Research Site
Floriana
Research Site
Valletta

Other trials in Malta

Latvia1 site

Research Site
Riga

Other trials in Latvia

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

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

All Colorectal Cancer trials

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.

Related trials for Colorectal Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

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.