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

September 24, 2012 updated by: AstraZeneca

A Study to Compare the Efficacy of AZD2171 in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) and the Efficacy of Bevacizumab in Combination With FOLFOX in the Second-line Treatment of Patients With Metastatic Colorectal Cancer

The primary purpose of this study is to compare the efficacy of AZD2171 in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Research Site
      • Wels, Austria
        • Research Site
      • Wien, Austria
        • Research Site
  • Belgium
      • Bonheiden, Belgium
        • Research Site
      • Brussels, Belgium
        • Ressearch Site
      • Edegem, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • Research Site
    • Ontario
      • Kingston, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Sudbury, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
  • Czech Republic
      • Chomutov, Czech Republic
        • Research Site
      • Nova Ves Pod Plesi, Czech Republic
        • Research Site
      • Pardubice, Czech Republic
        • Research Site
      • Praha, Czech Republic
        • Research Site
  • France
      • Montpellier, France
        • Research Site
      • Saint Herblain, France
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Freiburg, Germany
        • Research Site
      • Halle, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • München, Germany
        • Research Site
      • Stuttgart, Germany
        • Research Site
  • Italy
      • Genova, Italy
        • Research Site
      • La Torretta, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Rozzano, Italy
        • Research Site
  • Spain
      • A Coruña, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
  • United Kingdom
      • Glasgow, United Kingdom
        • Research Site
      • Ipswich, United Kingdom
        • Research Site
      • Maidstone, United Kingdom
        • Research Site
      • Newcastle-upon-tyne, United Kingdom
        • Research Site
      • Sutton, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of colon or rectal cancer,
  • Received prior systemic therapy for cancer,
  • Cancer must have progressed during or after first treatment

Exclusion Criteria:

  • Prior treatment with a VEGF inhibitor,
  • Poorly controlled hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Bevacizumab + FOLFOX
Drug: Leucovorin
intravenous infusion
Drug: Bevacizumab
intravenous infusion
Other Names:
  • Avastin®
Drug: 5-fluorouracil
intravenous infusion
Other Names:
  • 5-FU
Drug: Oxaliplatin
intravenous infusion
Other Names:
  • Eloxatin®
Experimental: 2
AZD2171 + FOLFOX
Drug: Leucovorin
intravenous infusion
Drug: AZD2171
oral tablet
Other Names:
  • RECENTIN™
  • cediranib
Drug: 5-fluorouracil
intravenous infusion
Other Names:
  • 5-FU
Drug: Oxaliplatin
intravenous infusion
Other Names:
  • Eloxatin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: Randomisation to data cut-off date of November 2007
Number of months from randomisation to the earlier date of objective progression or death
Randomisation to data cut-off date of November 2007

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: Randomisation to data cut-off date of November 2007

Per RECIST Criteria (V1.0) and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= ##% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Confirmed Partial Response (PR) or Complete Response (CR) as defined by RECIST.
Randomisation to data cut-off date of November 2007
Overall Survival
Time Frame: Randomisation to data cut-off date of 30 January 2009
Number of months from randomisation to the date of death from any cause
Randomisation to data cut-off date of 30 January 2009
Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)
Time Frame: Randomisation to data cut-off date of November 2007
Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires
Randomisation to data cut-off date of November 2007
QOL: Time to Worsening of Treatment-free Survival (TFS)
Time Frame: Randomisation to data cut-off date of November 2007
Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires
Randomisation to data cut-off date of November 2007
QOL: Time to Worsening of Clear Cell Sarcoma (CCS)
Time Frame: Randomisation to data cut-off date of November 2007
Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires
Randomisation to data cut-off date of November 2007
QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)
Time Frame: Randomisation to data cut-off date of November 2007
Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires
Randomisation to data cut-off date of November 2007

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

January 17, 2006

First Submitted That Met QC Criteria

January 17, 2006

First Posted (Estimate)

January 19, 2006

Study Record Updates

Last Update Posted (Estimate)

October 24, 2012

Last Update Submitted That Met QC Criteria

September 24, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8480C00041
  • EUDRACT number 2005-003443-31
  • HORIZON I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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