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First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX (HORIZON III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00384176
Recruitment Status : Completed
First Posted : October 5, 2006
Results First Posted : November 28, 2012
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Cediranib Drug: Bevacizumab Drug: 5-fluorouracil ( in FOLFOX) Drug: Leucovorin (in FOLFOX) Drug: Oxaliplatin (in FOLFOX) Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1814 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 30, 2006
Actual Primary Completion Date : November 15, 2009
Actual Study Completion Date : August 19, 2015
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Bevacizumab + FOLFOX
 Drug: Bevacizumab
intravenous infusion
Other Name: Avastin®

Drug: 5-fluorouracil ( in FOLFOX)
intravenous infusion
Other Name: 5-FU

Drug: Leucovorin (in FOLFOX)
intravenous infusion

Drug: Oxaliplatin (in FOLFOX)
intravenous infusion
Other Name: Eloxatin®
Experimental: 2
Cediranib + FOLFOX
 Drug: Cediranib
oral tablet once daily
Other Names:
  • RECENTIN™
  • AZD2171

Drug: 5-fluorouracil ( in FOLFOX)
intravenous infusion
Other Name: 5-FU

Drug: Leucovorin (in FOLFOX)
intravenous infusion

Drug: Oxaliplatin (in FOLFOX)
intravenous infusion
Other Name: Eloxatin®


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Randomisation until data cut-off ]
    Number of months from randomisation to the date of death from any cause

  2. Objective Response Rate [ Time Frame: Up until data cut-off ]

    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.


  3. Duration of Response [ Time Frame: Up until data cut-off date of 15/11/2007 ]
    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.

  4. Percentage Change in Tumour Size [ Time Frame: Baseline to Week 8 ]
    Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)*100

  5. 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 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384176


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Jane Robertson AstraZeneca
More Information
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Additional Information:
CSR-D8480C00013.pdf  This link exits the ClinicalTrials.gov site AstraZeneca Information - Outside of the US  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00384176    
Other Study ID Numbers: D8480C00013
Eudract Number 2005-003440-66
First Posted: October 5, 2006    Key Record Dates
Results First Posted: November 28, 2012
Last Update Posted: April 14, 2017
Last Verified: April 2017
Keywords provided by AstraZeneca:
Metastatic Colorectal Cancer
RECENTIN
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Bevacizumab
Oxaliplatin
Fluorouracil
 Cediranib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Antidotes
Protective Agents