Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer (HORIZON II)

November 7, 2016 updated by: AstraZeneca

A Randomised, Double-blind, Phase III Study to Compare the Efficacy and Safety of Cediranib (AZD2171, RECENTIN™) When Added to 5 Fluorouracil, Leucovorin and Oxaliplatin (FOLFOX) or Capecitabine and Oxaliplatin (XELOX) With the Efficacy and Safety of Placebo When Added to FOLFOX or XELOX in Patients With Previously Untreated Metastatic Colorectal Cancer.

The purpose of this study is to determine if Cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic colorectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1254

Phase

  • Phase 3

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

  • Argentina
      • Buenos Aires City, Argentina
        • Research Site
      • Capital Federal, Argentina
        • Research Site
      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Córdoba, Argentina
        • Research Site
      • Resistencia, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
      • Santa Fe, Argentina
        • Research Site
  • Australia
      • Ashford, Australia
        • Research Site
      • Camperdown, Australia
        • Research Site
      • Heidelberg, Australia
        • Research Site
      • Hornsby, Australia
        • Research Site
      • Liverpool, Australia
        • Research Site
      • Waratah, Australia
        • Research Site
      • Wodonga, Australia
        • Research Site
  • Brazil
      • Curitiba, Brazil
        • Research Site
      • Goiânia, Brazil
        • Research Site
      • Jaú, Brazil
        • Research Site
      • Porto Alegre, Brazil
        • Research Site
      • Rio de Janeiro, Brazil
        • Research Site
      • Salvador, Brazil
        • Research Site
      • Santo André, Brazil
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
      • São Paulo, Brazil
        • Research Site
  • Bulgaria
      • Plovdiv, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Stara Zagora, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
      • Veliko Tarnovo, Bulgaria
        • Research Site
      • Vratza, Bulgaria
        • Research Site
  • China
      • Beijing, China
        • Research Site
      • Changchun, China
        • Research Site
      • Chengdu, China
        • Research Site
      • ChongQing, China
        • Research Site
      • Fuzhou, China
        • Research Site
      • Guangzhou, China
        • Research Site
      • Hangzhou, China
        • Research Site
      • Nanjing, China
        • Research Site
      • Nanning, China
        • Research Site
      • Shanghai, China
        • Research Site
      • Tianjin, China
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Ceske Budejovice, Czech Republic
        • Research Site
      • Cheb, Czech Republic
        • Research Site
      • Jicin, Czech Republic
        • Research Site
      • Jihlava, Czech Republic
        • Research Site
      • Olomouc, Czech Republic
        • Research Site
      • Ostrava, Czech Republic
        • Research Site
      • Praha 6, Czech Republic
        • Research Site
      • Pribram - Zdabor, Czech Republic
        • Research Site
      • Sumperk, Czech Republic
        • Research Site
      • Zlin, Czech Republic
        • Research Site
      • Znojmo, Czech Republic
        • Research Site
  • Germany
      • Essen, Germany
        • Research Site
      • Freiburg, Germany
        • Research Site
      • Goslar, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Hildesheim, Germany
        • Research Site
      • Mannheim, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Györ, Hungary
        • Research Site
      • Kecskemét, Hungary
        • Research Site
      • Nyíregyháza, Hungary
        • Research Site
      • Szombathely, Hungary
        • Research Site
      • Zalaegerszeg, Hungary
        • Research Site
  • India
      • Hyderabad, India
        • Research Site
      • Trivandrum, India
        • Research Site
  • Korea, Republic of
      • Goyang-si, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
  • Philippines
      • Cebu City, Philippines
        • Research Site
      • Davao City, Philippines
        • Research Site
      • Iloilo, Philippines
        • Research Site
      • Quezon, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
  • Poland
      • Bydgoszcz, Poland
        • Research Site
      • Gdańsk, Poland
        • Research Site
      • Gliwice, Poland
        • Research Site
      • Kraków, Poland
        • Research Site
      • Olsztyn, Poland
        • Research Site
      • Toruń, Poland
        • Research Site
      • Wrocław, Poland
        • Research Site
  • Switzerland
      • Bellinzona, Switzerland
        • Research Site
      • Lausanne, Switzerland
        • Research Site
      • Locarno, Switzerland
        • Research Site
      • Zürich, Switzerland
        • Research Site
  • Taiwan
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
  • United Kingdom
      • Aberdeen, United Kingdom
        • Research Site
      • Belfast, United Kingdom
        • Research Site
      • Leicester, United Kingdom
        • Research Site
      • Manchester, 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 to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written Informed Consent
  • Carcinoma of the colon or rectum
  • One or more measurable lesions

Exclusion Criteria:

  • Adjuvant/neoadjuvant therapy within 6-12 months of study entry
  • Untreated unstable brain or meningeal metastases
  • Specific laboratory ranges
  • Specific cardiovascular problems
  • Participation in other trials within 30 days

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
Placebo Comparator: FOLFOX + placebo Cediranib
Drug: Cediranib Placebo
oral tablet
Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Other Names:
  • 5-FU
  • Other Names:
  • Eloxatin®
  • Drug: Leucovorin (in FOLFOX)
  • intravenous infusion
  • Drug: Oxaliplatin (in FOLFOX)
Placebo Comparator: Xelox + placebo Cediranib
Drug: Cediranib Placebo
oral tablet
Drug: XELOX (Capecitabine and Oxaliplatin)
intravenous oxaliplatin 130 mg/ m^2(day 1) followed by oral capecitabine 1,000 mg/ m^2twice daily (day 1 to day 15)
Other Names:
  • Xeloda® + Eloxatin®
Experimental: FOLFOX + Cediranib
Drug: Cediranib
oral tablet
Other Names:
  • RECENTIN™
  • AZD2171
Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Other Names:
  • 5-FU
  • Other Names:
  • Eloxatin®
  • Drug: Leucovorin (in FOLFOX)
  • intravenous infusion
  • Drug: Oxaliplatin (in FOLFOX)
Experimental: XELOX + Cediranib
Drug: Cediranib
oral tablet
Other Names:
  • RECENTIN™
  • AZD2171
Drug: XELOX (Capecitabine and Oxaliplatin)
intravenous oxaliplatin 130 mg/ m^2(day 1) followed by oral capecitabine 1,000 mg/ m^2twice daily (day 1 to day 15)
Other Names:
  • Xeloda® + Eloxatin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.
RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression [non-PD]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.
RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.
Overall Survival
Time Frame: Baseline through to date of death upto and including data cut off date of 21/03/10
Number of months from randomisation to the date of death from any cause
Baseline through to date of death upto and including data cut off date of 21/03/10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: Baseline through to date of death upto and including data cut off date of 21/03/10
Objective tumour response(defined as a confirmed response of CR or PR).The definition for a confirmed response was met when an initial RECIST response of PR/CR was confirmed at the next scheduled visit as a PR/CR according to an evaluable assessment.Intervening assessments of non-evaluable or stable disease were allowable as long as the initial RECIST response was confirmed.RECIST criteria defined as follows: Target lesions Complete Response(CR)Disappearance of all target lesions Partial Response (PR).At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Non-target lesions Complete Response (CR) Disappearance of all non-target lesi
Baseline through to date of death upto and including data cut off date of 21/03/10
Best Percentage Change in Tumour Size
Time Frame: Baseline through to date of death upto and including data cut off date of 21/03/10
Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions
Baseline through to date of death upto and including data cut off date of 21/03/10
Duration of Response
Time Frame: Treatment period from initial response up until data cut-off date of 21/03/10
Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies.
Treatment period from initial response up until data cut-off date of 21/03/10
Rate of Resection of Liver Metastases
Time Frame: Post-randomisation until end of study
Number of patients undergoing liver resection, based on patients with liver disease at baseline
Post-randomisation until end of study
Time to Wound Healing Complications
Time Frame: Post-randomisation until end of study
Number of days from post-randomisation surgery until wound healing complications
Post-randomisation until end of study

Collaborators and Investigators

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

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

November 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

November 13, 2006

First Submitted That Met QC Criteria

November 13, 2006

First Posted (Estimate)

November 14, 2006

Study Record Updates

Last Update Posted (Estimate)

December 28, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8480C00051
  • EUDRACT No 2006-001194-14
  • HORIZON II

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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