Colorectal CancerPhase 2HORIZON INCT00278889

Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)

A Phase 2 study testing AZD2171, 5-fluorouracil and Leucovorin in people with Colorectal Cancer, run by AstraZeneca at 43 sites in 9 countries.

Completed

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

Official record

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Trial summary

The primary purpose of this study is to compare the efficacy of AZD2171 in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer
What is being tested?: AZD2171, 5-fluorouracil and Leucovorin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 215 participants
Where: 43 sitesin 9 countries
Study dates: Jan 2006to Oct 2009
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of colon or rectal cancer,
Received prior systemic therapy for cancer,
Cancer must have progressed during or after first treatment

Who cannot join

Prior treatment with a VEGF inhibitor,
Poorly controlled hypertension

Trial locations and contacts

43 sites in 9 countries.

Country

City, postcode or hospital

43 sites in 9 countries

Canada7 sites

Research Site
Greater Sudbury, Ontario
Research Site
Kingston, Ontario
Research Site
Moncton, New Brunswick
Research Site
Montreal, Quebec
Research Site
Ottawa, Ontario
Research Site
Toronto, Ontario
Research Site
Winnipeg, Manitoba

Other trials in Canada

Germany7 sites

Research Site
Berlin
Research Site
Freiburg im Breisgau
Research Site
Halle
Research Site
Hanover
Research Site
Heidelberg
Research Site
München
Research Site
Stuttgart

Other trials in Germany

Belgium5 sites

Research Site
Bonheiden
Ressearch Site
Brussels
Research Site
Edegem
Research Site
Ghent
Research Site
Leuven

Other trials in Belgium

Italy5 sites

Research Site
Genova
Research Site
La Torretta
Research Site
Milan
Research Site
Naples
Research Site
Rozzano

Other trials in Italy

Spain5 sites

Research Site
A Coruña
Research Site
Barcelona
Research Site
Madrid
Research Site
Valencia
Research Site
Zaragoza

Other trials in Spain

United Kingdom5 sites

Research Site
Glasgow
Research Site
Ipswich
Research Site
Maidstone
Research Site
Newcastle upon Tyne
Research Site
Sutton

Other trials in United Kingdom

Czechia4 sites

Research Site
Chomutov
Research Site
Nová Ves pod Pleší
Research Site
Pardubice
Research Site
Prague

Other trials in Czechia

Austria3 sites

Research Site
Innsbruck
Research Site
Vienna
Research Site
Wels

Other trials in Austria

France2 sites

Research Site
Montpellier
Research Site
Saint-Herblain

Other trials in France

About this study

Official title: A Study to Compare the Efficacy of AZD2171 in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) and the Efficacy of Bevacizumab in Combination With FOLFOX in the Second-line Treatment of Patients With Metastatic Colorectal Cancer

Conditions: Colorectal Cancer
Being tested: AZD2171, 5-fluorouracil, Leucovorin, Oxaliplatin, Bevacizumab
Keywords: Colorectal Cancer, phase II, metastatic colorectal cancer, AZD2171, 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.

AZD2171Drug
Also called cediranib, RECENTIN™
oral tablet
5-fluorouracilDrug
Also called 5-FU
intravenous infusion
LeucovorinDrug
intravenous infusion
OxaliplatinDrug
Also called Eloxatin®
intravenous infusion
BevacizumabDrug
Also called Avastin®
intravenous infusion

Study groups in NCT00278889
Study group	Role	What they receive
1	Active comparator	Bevacizumab + FOLFOX Receives: Drug: 5-fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Bevacizumab
2	Experimental	AZD2171 + FOLFOX Receives: Drug: AZD2171; Drug: 5-fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin

What is being measured

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

Progression Free Survival
Number of months from randomisation to the earlier date of objective progression or death
Measured: Randomisation to data cut-off date of November 2007

Secondary outcomes (6)

Objective Response Rate
Per RECIST Criteria (V1.0) and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= ##% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Confirmed Partial Response (PR) or Complete Response (CR) as defined by RECIST.
Measured: Randomisation to data cut-off date of November 2007
Overall Survival
Number of months from randomisation to the date of death from any cause
Measured: Randomisation to data cut-off date of 30 January 2009
Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)
Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires
Measured: Randomisation to data cut-off date of November 2007
QOL: Time to Worsening of Treatment-free Survival (TFS)
Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires
Measured: Randomisation to data cut-off date of November 2007
QOL: Time to Worsening of Clear Cell Sarcoma (CCS)
Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires
Measured: Randomisation to data cut-off date of November 2007
QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)
Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires
Measured: Randomisation to data cut-off date of November 2007

Timeline

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

Jan 2006Oct 2009

First posted19 Jan 2006 (estimated)
Study startJan 2006
Primary completionNov 2007
Study completionOct 2009

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.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 215 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00278889
Sponsor's protocol ID: D8480C00041
Other IDs: EUDRACT number 2005-003443-31, HORIZON I
Acronym: HORIZON I
Status last verified: Sep 2012
First submitted: 17 Jan 2006
Last updated: 24 Oct 2012
Results posted: Yes, on ClinicalTrials.gov

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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Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
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All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Compare the Efficacy of AZD2171 in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) and the Efficacy of Bevacizumab in Combination With FOLFOX in the Second-line Treatment of Patients With Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT00278889
Acronym / sponsor ID: HORIZON I / D8480C00041
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer, phase II, metastatic colorectal cancer, AZD2171, RECENTIN
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 215 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2006
Primary completion: Nov 2007 (actual)
Study completion: Oct 2009 (actual)
First posted: 19 Jan 2006 (estimated)
Results: Posted 24 Oct 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: 5-fluorouracil, Drug: Leucovorin, Drug: Oxaliplatin, Drug: BevacizumabBevacizumab + FOLFOX
2	Experimental	Drug: AZD2171, Drug: 5-fluorouracil, Drug: Leucovorin, Drug: OxaliplatinAZD2171 + FOLFOX

Who may qualify

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

Key inclusion criteria (3 listed)

Clinical diagnosis of colon or rectal cancer,
Received prior systemic therapy for cancer,
Cancer must have progressed during or after first treatment

Key exclusion criteria (2 listed)

Prior treatment with a VEGF inhibitor,
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
AZD2171Also: cediranib, RECENTIN™oral tablet	Drug	2
5-fluorouracilAlso: 5-FUintravenous infusion	Drug	1, 2
Leucovorinintravenous infusion	Drug	1, 2
OxaliplatinAlso: Eloxatin®intravenous infusion	Drug	1, 2
BevacizumabAlso: Avastin®intravenous infusion	Drug	1

Primary outcome

Progression Free Survival
Time frame: Randomisation to data cut-off date of November 2007
Number of months from randomisation to the earlier date of objective progression or death

6 secondary outcomes

Objective Response Rate
Time frame: Randomisation to data cut-off date of November 2007
Overall Survival
Time frame: Randomisation to data cut-off date of 30 January 2009
Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)
Time frame: Randomisation to data cut-off date of November 2007
QOL: Time to Worsening of Treatment-free Survival (TFS)
Time frame: Randomisation to data cut-off date of November 2007
QOL: Time to Worsening of Clear Cell Sarcoma (CCS)
Time frame: Randomisation to data cut-off date of November 2007
QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)
Time frame: Randomisation to data cut-off date of November 2007

Results and safety

Results posted to the registry on 24 Oct 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
FOLFOX + Cediranib 20 mg	73	48
FOLFOX + Cediranib 30 mg	74	47
FOLFOX + Bevacizumab 10 mg/kg	68	48

Primary outcome: Progression Free Survival

Time frame: Randomisation to data cut-off date of November 2007. Median (Inter-Quartile Range). Unit: Months

Measure	FOLFOX + Cediranib 20 mg n = 71	FOLFOX + Cediranib 30 mg n = 73	FOLFOX + Bevacizumab 10 mg/kg n = 66
Value	5.8 (3.9 to 8.9)	7.2 (4.6 to 8.8)	7.8 (5.3 to 10.8)

6 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
FOLFOX + Cediranib 20 mg	30 of 73 (41.1%)	69 of 73 (94.5%)	Not reported
FOLFOX + Cediranib 30 mg	39 of 74 (52.7%)	73 of 74 (98.6%)	Not reported
FOLFOX + Bevacizumab 10 mg/kg	29 of 68 (42.6%)	66 of 68 (97.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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)
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RecruitingPhase 2
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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

43 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD2171, 5-fluorouracil and Leucovorin in people with Colorectal Cancer, run by AstraZeneca at 43 sites in 9 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 3 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 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Canada, Germany, Belgium, Italy, Spain and 4 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 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.

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 24 Oct 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: Randomisation to data cut-off date of November 2007). 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 NCT00278889.

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 24 Oct 2012.