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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)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD2171
5-fluorouracil
Leucovorin
Oxaliplatin
Bevacizumab
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, phase II, metastatic colorectal cancer, AZD2171, RECENTIN

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Bevacizumab + FOLFOX

AZD2171 + FOLFOX

Outcomes

Primary Outcome Measures

Progression Free Survival
Number of months from randomisation to the earlier date of objective progression or death

Secondary Outcome Measures

Objective Response Rate
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
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 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 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 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 when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires

Full Information

First Posted
January 17, 2006
Last Updated
September 24, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00278889
Brief Title
Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)
Acronym
HORIZON I
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer, phase II, metastatic colorectal cancer, AZD2171, RECENTIN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Bevacizumab + FOLFOX
Arm Title
2
Arm Type
Experimental
Arm Description
AZD2171 + FOLFOX
Intervention Type
Drug
Intervention Name(s)
AZD2171
Other Intervention Name(s)
cediranib, RECENTIN™
Intervention Description
oral tablet
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Other Intervention Name(s)
5-FU
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin®
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin®
Intervention Description
intravenous infusion
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Number of months from randomisation to the earlier date of objective progression or death
Time Frame
Randomisation to data cut-off date of November 2007
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
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.
Time Frame
Randomisation to data cut-off date of November 2007
Title
Overall Survival
Description
Number of months from randomisation to the date of death from any cause
Time Frame
Randomisation to data cut-off date of 30 January 2009
Title
Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)
Description
Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires
Time Frame
Randomisation to data cut-off date of November 2007
Title
QOL: Time to Worsening of Treatment-free Survival (TFS)
Description
Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires
Time Frame
Randomisation to data cut-off date of November 2007
Title
QOL: Time to Worsening of Clear Cell Sarcoma (CCS)
Description
Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires
Time Frame
Randomisation to data cut-off date of November 2007
Title
QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)
Description
Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires
Time Frame
Randomisation to data cut-off date of November 2007

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Robertson
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Innsbruck
Country
Austria
Facility Name
Research Site
City
Wels
Country
Austria
Facility Name
Research Site
City
Wien
Country
Austria
Facility Name
Research Site
City
Bonheiden
Country
Belgium
Facility Name
Ressearch Site
City
Brussels
Country
Belgium
Facility Name
Research Site
City
Edegem
Country
Belgium
Facility Name
Research Site
City
Gent
Country
Belgium
Facility Name
Research Site
City
Leuven
Country
Belgium
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Research Site
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
Research Site
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Sudbury
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Chomutov
Country
Czech Republic
Facility Name
Research Site
City
Nova Ves Pod Plesi
Country
Czech Republic
Facility Name
Research Site
City
Pardubice
Country
Czech Republic
Facility Name
Research Site
City
Praha
Country
Czech Republic
Facility Name
Research Site
City
Montpellier
Country
France
Facility Name
Research Site
City
Saint Herblain
Country
France
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Freiburg
Country
Germany
Facility Name
Research Site
City
Halle
Country
Germany
Facility Name
Research Site
City
Hannover
Country
Germany
Facility Name
Research Site
City
Heidelberg
Country
Germany
Facility Name
Research Site
City
München
Country
Germany
Facility Name
Research Site
City
Stuttgart
Country
Germany
Facility Name
Research Site
City
Genova
Country
Italy
Facility Name
Research Site
City
La Torretta
Country
Italy
Facility Name
Research Site
City
Milano
Country
Italy
Facility Name
Research Site
City
Napoli
Country
Italy
Facility Name
Research Site
City
Rozzano
Country
Italy
Facility Name
Research Site
City
A Coruña
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Valencia
Country
Spain
Facility Name
Research Site
City
Zaragoza
Country
Spain
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Ipswich
Country
United Kingdom
Facility Name
Research Site
City
Maidstone
Country
United Kingdom
Facility Name
Research Site
City
Newcastle-upon-tyne
Country
United Kingdom
Facility Name
Research Site
City
Sutton
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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