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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
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE October 3, 2006
First Posted Date  ICMJE October 5, 2006
Results First Submitted Date  ICMJE March 7, 2012
Results First Posted Date  ICMJE November 28, 2012
Last Update Posted Date April 14, 2017
Actual Study Start Date  ICMJE August 30, 2006
Actual Primary Completion Date November 15, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2006)
The efficacy of AZD2171 in combination with FOLFOX compared to the efficacy of bevacizumab in combination with FOLFOX by assessment of progression free survival.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2012)
  • Overall Survival [ Time Frame: Randomisation until data cut-off ]
    Number of months from randomisation to the date of death from any cause
  • 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.
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2006)
Assessment of overall survival and overall response rate, safety, tolerability and Quality of life when AZD2171 is combined with FOLFOX compared to Bevacizumab and FOLFOX
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Cediranib
    oral tablet once daily
    Other Names:
    • AZD2171
  • 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®
Study Arms  ICMJE
  • Active Comparator: 1
    Bevacizumab + FOLFOX
    • Drug: Bevacizumab
    • Drug: 5-fluorouracil ( in FOLFOX)
    • Drug: Leucovorin (in FOLFOX)
    • Drug: Oxaliplatin (in FOLFOX)
  • Experimental: 2
    Cediranib + FOLFOX
    • Drug: Cediranib
    • Drug: 5-fluorouracil ( in FOLFOX)
    • Drug: Leucovorin (in FOLFOX)
    • Drug: Oxaliplatin (in FOLFOX)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2017)
Original Enrollment  ICMJE
 (submitted: October 3, 2006)
Actual Study Completion Date  ICMJE August 19, 2015
Actual Primary Completion Date November 15, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Egypt,   Finland,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Latvia,   Malta,   Philippines,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States,   Vietnam
Removed Location Countries Greece,   Korea, Republic of,   Lithuania,   Malaysia,   Singapore,   Tunisia
Administrative Information
NCT Number  ICMJE NCT00384176
Other Study ID Numbers  ICMJE D8480C00013
Eudract Number 2005-003440-66
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party AstraZeneca
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE AstraZeneca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jane Robertson AstraZeneca
PRS Account AstraZeneca
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP