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Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer

NCT ID: NCT00851084

Last Updated: 2016-06-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-01-31

Brief Summary

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The primary objective of the study is to estimate the progression-free survival rate at 12 months for the two arms of the study.

Secondary objectives include the evaluation of overall objective response rate to treatment, progression-free survival, overall survival, safety and documentation of potential immunogenicity of aflibercept.

This study was a non-comparative randomized trial and was not powered for a comparison of any of the efficacy endpoints.

Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a check on the similarity of the current patients to the historical controls with respect to clinical outcome when given FOLFOX6 treatment.

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Detailed Description

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Conditions

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Colorectal Neoplasms Neoplasm Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mFOLFOX6 only

modified FOLFOX6 chemotherapy regimen

Group Type ACTIVE_COMPARATOR

oxaliplatin

Intervention Type DRUG

administration: IV infusion

5-FU

Intervention Type DRUG

administration: IV infusion

Folinic Acid

Intervention Type DRUG

administration: IV infusion

mFOLFOX6 + aflibercept

modified FOLFOX6 chemotherapy regimen in combination with aflibercept

Group Type EXPERIMENTAL

aflibercept

Intervention Type DRUG

administration: IV infusion

oxaliplatin

Intervention Type DRUG

administration: IV infusion

5-FU

Intervention Type DRUG

administration: IV infusion

Folinic Acid

Intervention Type DRUG

administration: IV infusion

Interventions

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aflibercept

administration: IV infusion

Intervention Type DRUG

oxaliplatin

administration: IV infusion

Intervention Type DRUG

5-FU

administration: IV infusion

Intervention Type DRUG

Folinic Acid

administration: IV infusion

Intervention Type DRUG

Other Intervention Names

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ZALTRAP™ AVE0005

Eligibility Criteria

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Inclusion Criteria

* Histologically proven adenocarcinoma of the colon or the rectum
* Metastatic disease not amenable to potentially curative treatment

Exclusion Criteria

* Prior therapy for metastatic cancer of the colon or the rectum
* Prior treatment with angiogenesis inhibitors

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Zalcberg, MD

Role: PRINCIPAL_INVESTIGATOR

Peter Mc Callum Cancer Centre, Melbourne, Australia

Locations

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Sanofi-Aventis Investigational Site Number 036004

Douglas, , Australia

Site Status

Sanofi-Aventis Investigational Site Number 036001

Hunter Region Mail Centre, , Australia

Site Status

Sanofi-Aventis Investigational Site Number 036003

Hunter Region Mail Centre, , Australia

Site Status

Sanofi-Aventis Investigational Site Number 276003

Berlin, , Germany

Site Status

Sanofi-Aventis Investigational Site Number 276007

Dresden, , Germany

Site Status

Sanofi-Aventis Investigational Site Number 276001

Hanover, , Germany

Site Status

Sanofi-Aventis Investigational Site Number 276006

Homberg (Efze), , Germany

Site Status

Sanofi-Aventis Investigational Site Number 276004

Mannheim, , Germany

Site Status

Sanofi-Aventis Investigational Site Number 276002

Münster, , Germany

Site Status

Sanofi-Aventis Investigational Site Number 276005

Recklinghausen, , Germany

Site Status

Sanofi-Aventis Investigational Site Number 380005

Bari, , Italy

Site Status

Sanofi-Aventis Investigational Site Number 380001

Florence, , Italy

Site Status

Sanofi-Aventis Investigational Site Number 380002

Milan, , Italy

Site Status

Sanofi-Aventis Investigational Site Number 380003

Taormina, , Italy

Site Status

Sanofi-Aventis Investigational Site Number 380004

Torino, , Italy

Site Status

Sanofi-Aventis Investigational Site Number 643002

Pyatigorsk, , Russia

Site Status

Sanofi-Aventis Investigational Site Number 643005

Saint Petersburg, , Russia

Site Status

Sanofi-Aventis Investigational Site Number 643001

Sochi, , Russia

Site Status

Sanofi-Aventis Investigational Site Number 410003

Busan, , South Korea

Site Status

Sanofi-Aventis Investigational Site Number 410004

Cheongju-si, , South Korea

Site Status

Sanofi-Aventis Investigational Site Number 410005

Daegu, , South Korea

Site Status

Sanofi-Aventis Investigational Site Number 410002

Daejeon, , South Korea

Site Status

Sanofi-Aventis Investigational Site Number 410007

Goyang-Si, Gyeonggi-Do, , South Korea

Site Status

Sanofi-Aventis Investigational Site Number 410006

Seoul, , South Korea

Site Status

Sanofi-Aventis Investigational Site Number 410001

Seoul, , South Korea

Site Status

Sanofi-Aventis Investigational Site Number 410008

Ulsan, , South Korea

Site Status

Sanofi-Aventis Investigational Site Number 724005

Barcelona, , Spain

Site Status

Sanofi-Aventis Investigational Site Number 724004

Madrid, , Spain

Site Status

Sanofi-Aventis Investigational Site Number 724001

Madrid, , Spain

Site Status

Sanofi-Aventis Investigational Site Number 724002

Sabadell, , Spain

Site Status

Sanofi-Aventis Investigational Site Number 724007

Santiago de Compostela, , Spain

Site Status

Sanofi-Aventis Investigational Site Number 724003

Valencia, , Spain

Site Status

Sanofi-Aventis Investigational Site Number 826004

Leeds, , United Kingdom

Site Status

Sanofi-Aventis Investigational Site Number 826001

Leicester, , United Kingdom

Site Status

Sanofi-Aventis Investigational Site Number 826002

Manchester, , United Kingdom

Site Status

Sanofi-Aventis Investigational Site Number 826003

Slough, , United Kingdom

Site Status

Sanofi-Aventis Investigational Site Number 826005

Southampton, , United Kingdom

Site Status

Countries

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Australia Germany Italy Russia South Korea Spain United Kingdom

References

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Folprecht G, Pericay C, Saunders MP, Thomas A, Lopez Lopez R, Roh JK, Chistyakov V, Hohler T, Kim JS, Hofheinz RD, Ackland SP, Swinson D, Kopp M, Udovitsa D, Hall M, Iveson T, Vogel A, Zalcberg JR. Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with or without aflibercept in first-line treatment of patients with metastatic colorectal cancer: the AFFIRM study. Ann Oncol. 2016 Jul;27(7):1273-9. doi: 10.1093/annonc/mdw176. Epub 2016 Apr 18.

Reference Type RESULT
PMID: 27091810 (View on PubMed)

Other Identifiers

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EFC10668

Identifier Type: -

Identifier Source: org_study_id

EudraCT 2008-004178-41

Identifier Type: -

Identifier Source: secondary_id

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