We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00384176
First Posted: October 5, 2006
Last Update Posted: April 14, 2017
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.
Information provided by (Responsible Party):
AstraZeneca
October 3, 2006
October 5, 2006
March 7, 2012
November 28, 2012
April 14, 2017
August 30, 2006
November 15, 2009   (Final data collection date for primary outcome measure)
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.
The efficacy of AZD2171 in combination with FOLFOX compared to the efficacy of bevacizumab in combination with FOLFOX by assessment of progression free survival.
Complete list of historical versions of study NCT00384176 on ClinicalTrials.gov Archive Site
  • 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.
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
Not Provided
Not Provided
 
First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX
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
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: Cediranib
    oral tablet once daily
    Other Names:
    • RECENTIN™
    • 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®
  • Active Comparator: 1
    Bevacizumab + FOLFOX
    Interventions:
    • Drug: Bevacizumab
    • Drug: 5-fluorouracil ( in FOLFOX)
    • Drug: Leucovorin (in FOLFOX)
    • Drug: Oxaliplatin (in FOLFOX)
  • Experimental: 2
    Cediranib + FOLFOX
    Interventions:
    • Drug: Cediranib
    • Drug: 5-fluorouracil ( in FOLFOX)
    • Drug: Leucovorin (in FOLFOX)
    • Drug: Oxaliplatin (in FOLFOX)
Robertson JD, Botwood NA, Rothenberg ML, Schmoll HJ. Phase III trial of FOLFOX plus bevacizumab or cediranib (AZD2171) as first-line treatment of patients with metastatic colorectal cancer: HORIZON III. Clin Colorectal Cancer. 2009 Jan;8(1):59-60. doi: 10.3816/CCC.2009.n.010.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1814
August 19, 2015
November 15, 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 130 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
Greece,   Korea, Republic of,   Lithuania,   Malaysia,   Singapore,   Tunisia
 
NCT00384176
D8480C00013
Eudract Number 2005-003440-66
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Jane Robertson AstraZeneca
AstraZeneca
April 2017

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