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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00278889
First received: January 17, 2006
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Colorectal Cancer
 Drug: AZD2171
Drug: 5-fluorouracil
Drug: Leucovorin
Drug: Oxaliplatin
Drug: Bevacizumab
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Randomisation to data cut-off date of November 2007 ] [ Designated as safety issue: No ]
    Number of months from randomisation to the earlier date of objective progression or death


Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: Randomisation to data cut-off date of November 2007 ] [ Designated as safety issue: No ]

    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.


  • Overall Survival [ Time Frame: Randomisation to data cut-off date of 30 January 2009 ] [ Designated as safety issue: No ]
    Number of months from randomisation to the date of death from any cause

  • Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI) [ Time Frame: Randomisation to data cut-off date of November 2007 ] [ Designated as safety issue: No ]
    Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires

  • QOL: Time to Worsening of Treatment-free Survival (TFS) [ Time Frame: Randomisation to data cut-off date of November 2007 ] [ Designated as safety issue: No ]
    Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires

  • QOL: Time to Worsening of Clear Cell Sarcoma (CCS) [ Time Frame: Randomisation to data cut-off date of November 2007 ] [ Designated as safety issue: No ]
    Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires

  • QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI) [ Time Frame: Randomisation to data cut-off date of November 2007 ] [ Designated as safety issue: No ]
    Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires


Enrollment: 215
Study Start Date: January 2006
Study Completion Date: October 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Bevacizumab + FOLFOX
 Drug: 5-fluorouracil
intravenous infusion
Other Name: 5-FU
Drug: Leucovorin
intravenous infusion
Drug: Oxaliplatin
intravenous infusion
Other Name: Eloxatin®
Drug: Bevacizumab
intravenous infusion
Other Name: Avastin®
Experimental: 2
AZD2171 + FOLFOX
 Drug: AZD2171
oral tablet
Other Names:
  • cediranib
  • RECENTIN™
Drug: 5-fluorouracil
intravenous infusion
Other Name: 5-FU
Drug: Leucovorin
intravenous infusion
Drug: Oxaliplatin
intravenous infusion
Other Name: Eloxatin®

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278889

  Show 43 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jane Robertson AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00278889     History of Changes
Other Study ID Numbers: D8480C00041, EUDRACT number 2005-003443-31, HORIZON I
Study First Received: January 17, 2006
Results First Received: July 26, 2012
Last Updated: September 24, 2012
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by AstraZeneca:
Colorectal Cancer
phase II
metastatic colorectal cancer
AZD2171
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
Oxaliplatin
Bevacizumab
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 16, 2013