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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00278889
First received: January 17, 2006
Last updated: September 24, 2012
Last verified: September 2012
Results First Received: July 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Drug: AZD2171
Drug: 5-fluorouracil
Drug: Leucovorin
Drug: Oxaliplatin
Drug: Bevacizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
FOLFOX + Cediranib 20 mg FOLFOX + Cediranib 20 mg
FOLFOX + Cediranib 30 mg FOLFOX + Cediranib 30 mg
FOLFOX + Bevacizumab 10 mg/kg FOLFOX + Bevacizumab 10 mg/kg

Participant Flow:   Overall Study
    FOLFOX + Cediranib 20 mg     FOLFOX + Cediranib 30 mg     FOLFOX + Bevacizumab 10 mg/kg  
STARTED     73 [1]   74 [1]   68 [1]
Overall Survival Analysis     16 [2]   20 [2]   19 [2]
COMPLETED     48 [3]   47 [3]   48 [3]
NOT COMPLETED     25     27     20  
Withdrawal by Subject                 0                 5                 3  
Lost to Follow-up                 1                 1                 0  
Death                 24                 21                 17  
[1] Randomised
[2] Ongoing at data cut-off for OS analysis (30 January 2009)
[3] Ongoing at data cut-off for PFS analysis (November 2007)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
FOLFOX + Cediranib 20 mg FOLFOX + Cediranib 20 mg
FOLFOX + Cediranib 30 mg FOLFOX + Cediranib 30 mg
FOLFOX + Bevacizumab 10 mg/kg FOLFOX + Bevacizumab 10 mg/kg
Total Total of all reporting groups

Baseline Measures
    FOLFOX + Cediranib 20 mg     FOLFOX + Cediranib 30 mg     FOLFOX + Bevacizumab 10 mg/kg     Total  
Number of Participants  
[units: participants]
  71     73     66     210  
Age  
[units: Years]
Mean ± Standard Deviation
       
Age     63.9  ± 8.7     63.5  ± 9.6     61.8  ± 10.6     63.07  ± 9.63  
Gender  
[units: Participants]
       
Female     22     26     27     75  
Male     49     47     39     135  



  Outcome Measures
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1.  Primary:   Progression Free Survival   [ Time Frame: Randomisation to data cut-off date of November 2007 ]

2.  Secondary:   Objective Response Rate   [ Time Frame: Randomisation to data cut-off date of November 2007 ]

3.  Secondary:   Overall Survival   [ Time Frame: Randomisation to data cut-off date of 30 January 2009 ]

4.  Secondary:   Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)   [ Time Frame: Randomisation to data cut-off date of November 2007 ]

5.  Secondary:   QOL: Time to Worsening of Treatment-free Survival (TFS)   [ Time Frame: Randomisation to data cut-off date of November 2007 ]

6.  Secondary:   QOL: Time to Worsening of Clear Cell Sarcoma (CCS)   [ Time Frame: Randomisation to data cut-off date of November 2007 ]

7.  Secondary:   QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)   [ Time Frame: Randomisation to data cut-off date of November 2007 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00278889     History of Changes
Other Study ID Numbers: D8480C00041, EUDRACT number 2005-003443-31, HORIZON I
Study First Received: January 17, 2006
Results First Received: July 26, 2012
Last Updated: September 24, 2012
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP