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

NCT ID: NCT00278889

Last Updated: 2012-10-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Colorectal Cancer phase II metastatic colorectal cancer AZD2171 RECENTIN

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Bevacizumab + FOLFOX

Group Type ACTIVE_COMPARATOR

5-fluorouracil

Intervention Type DRUG

intravenous infusion

Leucovorin

Intervention Type DRUG

intravenous infusion

Oxaliplatin

Intervention Type DRUG

intravenous infusion

Bevacizumab

Intervention Type DRUG

intravenous infusion

2

AZD2171 + FOLFOX

Group Type EXPERIMENTAL

AZD2171

Intervention Type DRUG

oral tablet

5-fluorouracil

Intervention Type DRUG

intravenous infusion

Leucovorin

Intervention Type DRUG

intravenous infusion

Oxaliplatin

Intervention Type DRUG

intravenous infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD2171

oral tablet

Intervention Type DRUG

5-fluorouracil

intravenous infusion

Intervention Type DRUG

Leucovorin

intravenous infusion

Intervention Type DRUG

Oxaliplatin

intravenous infusion

Intervention Type DRUG

Bevacizumab

intravenous infusion

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

cediranib RECENTIN™ 5-FU Eloxatin® Avastin®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jane Robertson

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Innsbruck, , Austria

Site Status

Research Site

Vienna, , Austria

Site Status

Research Site

Wels, , Austria

Site Status

Research Site

Bonheiden, , Belgium

Site Status

Ressearch Site

Brussels, , Belgium

Site Status

Research Site

Edegem, , Belgium

Site Status

Research Site

Ghent, , Belgium

Site Status

Research Site

Leuven, , Belgium

Site Status

Research Site

Winnipeg, Manitoba, Canada

Site Status

Research Site

Moncton, New Brunswick, Canada

Site Status

Research Site

Greater Sudbury, Ontario, Canada

Site Status

Research Site

Kingston, Ontario, Canada

Site Status

Research Site

Ottawa, Ontario, Canada

Site Status

Research Site

Toronto, Ontario, Canada

Site Status

Research Site

Montreal, Quebec, Canada

Site Status

Research Site

Chomutov, , Czechia

Site Status

Research Site

Nová Ves pod Pleší, , Czechia

Site Status

Research Site

Pardubice, , Czechia

Site Status

Research Site

Prague, , Czechia

Site Status

Research Site

Montpellier, , France

Site Status

Research Site

Saint-Herblain, , France

Site Status

Research Site

Berlin, , Germany

Site Status

Research Site

Freiburg im Breisgau, , Germany

Site Status

Research Site

Halle, , Germany

Site Status

Research Site

Hanover, , Germany

Site Status

Research Site

Heidelberg, , Germany

Site Status

Research Site

München, , Germany

Site Status

Research Site

Stuttgart, , Germany

Site Status

Research Site

Genova, , Italy

Site Status

Research Site

La Torretta, , Italy

Site Status

Research Site

Milan, , Italy

Site Status

Research Site

Napoli, , Italy

Site Status

Research Site

Rozzano, , Italy

Site Status

Research Site

A Coruña, , Spain

Site Status

Research Site

Barcelona, , Spain

Site Status

Research Site

Madrid, , Spain

Site Status

Research Site

Valencia, , Spain

Site Status

Research Site

Zaragoza, , Spain

Site Status

Research Site

Glasgow, , United Kingdom

Site Status

Research Site

Ipswich, , United Kingdom

Site Status

Research Site

Maidstone, , United Kingdom

Site Status

Research Site

Newcastle upon Tyne, , United Kingdom

Site Status

Research Site

Sutton, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria Belgium Canada Czechia France Germany Italy Spain United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EUDRACT number 2005-003443-31

Identifier Type: -

Identifier Source: secondary_id

HORIZON I

Identifier Type: -

Identifier Source: secondary_id

D8480C00041

Identifier Type: -

Identifier Source: org_study_id