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Completed

NCT Number: NCT00399035

Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With 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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cediranib

Drug

oral tablet

Other names: AZD2171, RECENTIN™

FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

Drug

intravenous infusion

Other names: Other Names:, 5-FU, Drug: Leucovorin (in FOLFOX), intravenous infusion, Drug: Oxaliplatin (in FOLFOX), Eloxatin®

XELOX (Capecitabine and Oxaliplatin)

Drug

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®

Cediranib Placebo

Drug

oral tablet

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. Time to Wound Healing Complications

    Time frame: Post-randomisation until end of study

    Number of days from post-randomisation surgery until wound healing complications

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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.

Acronym: HORIZON II

Important dates

Study start
2006
Primary completion
2010
Study completion
2016
First posted
Nov 14, 2006
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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