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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
  Purpose
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 Intervention 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 Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 1814
Actual Study Start Date: August 30, 2006
Study Completion Date: August 19, 2015
Primary Completion Date: November 15, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

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.


Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
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
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


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Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jane Robertson AstraZeneca
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00384176     History of Changes
Other Study ID Numbers: D8480C00013
Eudract Number 2005-003440-66
First Submitted: October 3, 2006
First Posted: October 5, 2006
Results First Submitted: March 7, 2012
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:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Oxaliplatin
Cediranib
Fluorouracil
Leucovorin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Antidotes
Protective Agents
Vitamin B Complex