Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)
HORIZON I
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
3 other identifiers
interventional
215
9 countries
43
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 colorectal-cancer
Started Jan 2006
Typical duration for phase_2 colorectal-cancer
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 17, 2006
CompletedFirst Posted
Study publicly available on registry
January 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
October 24, 2012
CompletedOctober 24, 2012
September 1, 2012
1.8 years
January 17, 2006
July 26, 2012
September 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
Number of months from randomisation to the earlier date of objective progression or death
Randomisation to data cut-off date of November 2007
Secondary Outcomes (6)
Objective Response Rate
Randomisation to data cut-off date of November 2007
Overall Survival
Randomisation to data cut-off date of 30 January 2009
Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)
Randomisation to data cut-off date of November 2007
QOL: Time to Worsening of Treatment-free Survival (TFS)
Randomisation to data cut-off date of November 2007
QOL: Time to Worsening of Clear Cell Sarcoma (CCS)
Randomisation to data cut-off date of November 2007
- +1 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORBevacizumab + FOLFOX
2
EXPERIMENTALAZD2171 + FOLFOX
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of colon or rectal cancer,
- Received prior systemic therapy for cancer,
- Cancer must have progressed during or after first treatment
You may not qualify if:
- Prior treatment with a VEGF inhibitor,
- Poorly controlled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (43)
Research Site
Innsbruck, Austria
Research Site
Vienna, Austria
Research Site
Wels, Austria
Research Site
Bonheiden, Belgium
Ressearch Site
Brussels, Belgium
Research Site
Edegem, Belgium
Research Site
Ghent, Belgium
Research Site
Leuven, Belgium
Research Site
Winnipeg, Manitoba, Canada
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Moncton, New Brunswick, Canada
Research Site
Greater Sudbury, Ontario, Canada
Research Site
Kingston, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Chomutov, Czechia
Research Site
Nová Ves pod Pleší, Czechia
Research Site
Pardubice, Czechia
Research Site
Prague, Czechia
Research Site
Montpellier, France
Research Site
Saint-Herblain, France
Research Site
Berlin, Germany
Research Site
Freiburg im Breisgau, Germany
Research Site
Halle, Germany
Research Site
Hanover, Germany
Research Site
Heidelberg, Germany
Research Site
München, Germany
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Stuttgart, Germany
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Genova, Italy
Research Site
La Torretta, Italy
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Milan, Italy
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Napoli, Italy
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Rozzano, Italy
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A Coruña, Spain
Research Site
Barcelona, Spain
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Madrid, Spain
Research Site
Valencia, Spain
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Zaragoza, Spain
Research Site
Glasgow, United Kingdom
Research Site
Ipswich, United Kingdom
Research Site
Maidstone, United Kingdom
Research Site
Newcastle upon Tyne, United Kingdom
Research Site
Sutton, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Jane Robertson
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2006
First Posted
January 19, 2006
Study Start
January 1, 2006
Primary Completion
November 1, 2007
Study Completion
October 1, 2009
Last Updated
October 24, 2012
Results First Posted
October 24, 2012
Record last verified: 2012-09