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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:
ClinicalTrials.gov Identifier:
NCT00278889
First Posted: January 19, 2006
Last Update Posted: October 24, 2012
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.
Information provided by (Responsible Party):
AstraZeneca
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]

    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00278889


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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00278889     History of Changes
Other Study ID Numbers: D8480C00041
EUDRACT number 2005-003443-31
HORIZON I
First Submitted: January 17, 2006
First Posted: January 19, 2006
Results First Submitted: July 26, 2012
Results First Posted: October 24, 2012
Last Update Posted: October 24, 2012
Last Verified: September 2012

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
Bevacizumab
Oxaliplatin
Cediranib
Fluorouracil
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Protein Kinase Inhibitors
Enzyme Inhibitors