- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00278889
Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX) (HORIZON I)
September 24, 2012 updated by: AstraZeneca
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
215
Phase
- Phase 2
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
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Innsbruck, Austria
- Research Site
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Wels, Austria
- Research Site
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Wien, Austria
- Research Site
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Bonheiden, Belgium
- Research Site
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Brussels, Belgium
- Ressearch Site
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Edegem, Belgium
- Research Site
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Gent, Belgium
- Research Site
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Leuven, Belgium
- Research Site
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Manitoba
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Winnipeg, Manitoba, Canada
- Research Site
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New Brunswick
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Moncton, New Brunswick, Canada
- Research Site
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Ontario
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Kingston, Ontario, Canada
- Research Site
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Ottawa, Ontario, Canada
- Research Site
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Sudbury, Ontario, Canada
- Research Site
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Toronto, Ontario, Canada
- Research Site
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Quebec
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Montreal, Quebec, Canada
- Research Site
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Chomutov, Czech Republic
- Research Site
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Nova Ves Pod Plesi, Czech Republic
- Research Site
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Pardubice, Czech Republic
- Research Site
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Praha, Czech Republic
- Research Site
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Montpellier, France
- Research Site
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Saint Herblain, France
- Research Site
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Berlin, Germany
- Research Site
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Freiburg, Germany
- Research Site
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Halle, Germany
- Research Site
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Hannover, Germany
- Research Site
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Heidelberg, Germany
- Research Site
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München, Germany
- Research Site
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Stuttgart, Germany
- Research Site
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Genova, Italy
- Research Site
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La Torretta, Italy
- Research Site
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Milano, Italy
- Research Site
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Napoli, Italy
- Research Site
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Rozzano, Italy
- Research Site
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A Coruña, Spain
- Research Site
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Barcelona, Spain
- Research Site
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Madrid, Spain
- Research Site
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Valencia, Spain
- Research Site
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Zaragoza, Spain
- Research Site
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Glasgow, United Kingdom
- Research Site
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Ipswich, United Kingdom
- Research Site
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Maidstone, United Kingdom
- Research Site
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Newcastle-upon-tyne, United Kingdom
- Research Site
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Sutton, United Kingdom
- Research Site
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of colon or rectal cancer,
- Received prior systemic therapy for cancer,
- Cancer must have progressed during or after first treatment
Exclusion Criteria:
- Prior treatment with a VEGF inhibitor,
- 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 |
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Active Comparator: 1
Bevacizumab + FOLFOX
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intravenous infusion
intravenous infusion
Other Names:
intravenous infusion
Other Names:
intravenous infusion
Other Names:
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Experimental: 2
AZD2171 + FOLFOX
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intravenous infusion
oral tablet
Other Names:
intravenous infusion
Other Names:
intravenous infusion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression Free Survival
Time Frame: Randomisation to data cut-off date of November 2007
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Number of months from randomisation to the earlier date of objective progression or death
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Randomisation to data cut-off date of November 2007
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Objective Response Rate
Time Frame: Randomisation to data cut-off date of November 2007
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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. |
Randomisation to data cut-off date of November 2007
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Overall Survival
Time Frame: Randomisation to data cut-off date of 30 January 2009
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Number of months from randomisation to the date of death from any cause
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Randomisation to data cut-off date of 30 January 2009
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Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)
Time Frame: Randomisation to data cut-off date of November 2007
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Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires
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Randomisation to data cut-off date of November 2007
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QOL: Time to Worsening of Treatment-free Survival (TFS)
Time Frame: Randomisation to data cut-off date of November 2007
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Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires
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Randomisation to data cut-off date of November 2007
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QOL: Time to Worsening of Clear Cell Sarcoma (CCS)
Time Frame: Randomisation to data cut-off date of November 2007
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Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires
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Randomisation to data cut-off date of November 2007
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QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)
Time Frame: Randomisation to data cut-off date of November 2007
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Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires
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Randomisation to data cut-off date of November 2007
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2006
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
January 17, 2006
First Submitted That Met QC Criteria
January 17, 2006
First Posted (Estimate)
January 19, 2006
Study Record Updates
Last Update Posted (Estimate)
October 24, 2012
Last Update Submitted That Met QC Criteria
September 24, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Micronutrients
- Protein Kinase Inhibitors
- Vitamins
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Bevacizumab
- Leucovorin
- Cediranib
Other Study ID Numbers
- D8480C00041
- EUDRACT number 2005-003443-31
- HORIZON I
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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Marks, John, M.D.TerminatedRectal NeoplasmsUnited States
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Fudan UniversityUnknown
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Zealand University HospitalRecruitingIntestinal Neoplasms | Colorectal Cancer | Rectal Cancer | Rectal Neoplasms | Colorectal Neoplasm | Chemotherapy Effect | Intestinal DiseaseDenmark
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