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Trial record 23 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

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

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.
 
ClinicalTrials.gov Identifier: NCT00399035
Recruitment Status : Completed
First Posted : November 14, 2006
Results First Posted : October 30, 2012
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Cediranib Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) Drug: XELOX (Capecitabine and Oxaliplatin) Drug: Cediranib Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : November 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
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®




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00399035


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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Jane Robertson AstraZeneca

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00399035     History of Changes
Other Study ID Numbers: D8480C00051
EUDRACT No 2006-001194-14
HORIZON II
First Posted: November 14, 2006    Key Record Dates
Results First Posted: October 30, 2012
Last Update Posted: December 28, 2016
Last Verified: October 2016
Keywords provided by AstraZeneca:
Colorectal Cancer
Cediranib
RECENTIN
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Fluorouracil
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Oxaliplatin
Cediranib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances