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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00384176
First received: October 3, 2006
Last updated: March 1, 2013
Last verified: March 2013
History of Changes

October 3, 2006
March 1, 2013
August 2006
November 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    Number of months from randomisation to the date of death from any cause
  • Objective Response Rate [ Time Frame: Up until data cut-off ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1805
August 2013
November 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Egypt,   Finland,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Malta,   Philippines,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   Vietnam
 
NCT00384176
D8480C00013, Eudract Number 2005-003440-66
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Jane Robertson AstraZeneca
AstraZeneca
March 2013

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