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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
Austria
Research Site
Innsbruck, Austria
Research Site
Wels, Austria
Research Site
Wien, Austria
Belgium
Research Site
Bonheiden, Belgium
Ressearch Site
Brussels, Belgium
Research Site
Edegem, Belgium
Research Site
Gent, Belgium
Research Site
Leuven, Belgium
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada
Canada, New Brunswick
Research Site
Moncton, New Brunswick, Canada
Canada, Ontario
Research Site
Kingston, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Sudbury, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Canada, Quebec
Research Site
Montreal, Quebec, Canada
Czech Republic
Research Site
Chomutov, Czech Republic
Research Site
Nova Ves Pod Plesi, Czech Republic
Research Site
Pardubice, Czech Republic
Research Site
Praha, Czech Republic
France
Research Site
Montpellier, France
Research Site
Saint Herblain, France
Germany
Research Site
Berlin, Germany
Research Site
Freiburg, Germany
Research Site
Halle, Germany
Research Site
Hannover, Germany
Research Site
Heidelberg, Germany
Research Site
München, Germany
Research Site
Stuttgart, Germany
Italy
Research Site
Genova, Italy
Research Site
La Torretta, Italy
Research Site
Milano, Italy
Research Site
Napoli, Italy
Research Site
Rozzano, Italy
Spain
Research Site
A Coruña, Spain
Research Site
Barcelona, Spain
Research Site
Madrid, Spain
Research Site
Valencia, Spain
Research Site
Zaragoza, Spain
United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
Ipswich, United Kingdom
Research Site
Maidstone, United Kingdom
Research Site
Newcastle-upon-tyne, United Kingdom
Research Site
Sutton, United Kingdom
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: Federal Agency for Medicines and Health Products, FAMHP

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 July 22, 2014