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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00399035
First received: November 13, 2006
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Metastatic Colorectal Cancer
 Drug: Cediranib
Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
Drug: XELOX (Capecitabine and Oxaliplatin)
Drug: Cediranib Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • Overall Survival [ Time Frame: Baseline through to date of death upto and including data cut off date of 21/03/10 ] [ Designated as safety issue: No ]
    Number of months from randomisation to the date of death from any cause


Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: Baseline through to date of death upto and including data cut off date of 21/03/10 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions

  • Duration of Response [ Time Frame: Treatment period from initial response up until data cut-off date of 21/03/10 ] [ Designated as safety issue: No ]
    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.

  • Rate of Resection of Liver Metastases [ Time Frame: Post-randomisation until end of study ] [ Designated as safety issue: No ]
    Number of patients undergoing liver resection, based on patients with liver disease at baseline

  • Time to Wound Healing Complications [ Time Frame: Post-randomisation until end of study ] [ Designated as safety issue: No ]
    Number of days from post-randomisation surgery until wound healing complications


Enrollment: 1076
Study Start Date: November 2006
Estimated Study Completion Date: May 2013
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: FOLFOX + placebo Cediranib
FOLFOX + placebo Cediranib
 Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Other Names:
  • Other Names:
  • 5-FU
  • Drug: Leucovorin (in FOLFOX)
  • intravenous infusion
  • Drug: Oxaliplatin (in FOLFOX)
  • Eloxatin®
Drug: Cediranib Placebo
oral tablet
Placebo Comparator: Xelox + placebo Cediranib
Xelox + placebo Cediranib
 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 Name: Xeloda® + Eloxatin®
Drug: Cediranib Placebo
oral tablet
Experimental: FOLFOX + Cediranib
FOLFOX + Cediranib
 Drug: Cediranib
oral tablet
Other Names:
  • AZD2171
  • RECENTIN™
Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Other Names:
  • Other Names:
  • 5-FU
  • Drug: Leucovorin (in FOLFOX)
  • intravenous infusion
  • Drug: Oxaliplatin (in FOLFOX)
  • Eloxatin®
Experimental: XELOX + Cediranib
XELOX + Cediranib
 Drug: Cediranib
oral tablet
Other Names:
  • AZD2171
  • RECENTIN™
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 Name: Xeloda® + Eloxatin®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399035

  Show 95 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jane Robertson AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00399035     History of Changes
Other Study ID Numbers: D8480C00051, EUDRACT No 2006-001194-14, HORIZON II
Study First Received: November 13, 2006
Results First Received: March 29, 2012
Last Updated: March 1, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control

Keywords provided by AstraZeneca:
Colorectal Cancer
Cediranib
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
Fluorouracil
Capecitabine
Oxaliplatin
Leucovorin
 Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes

ClinicalTrials.gov processed this record on May 22, 2013