AzTrials
AzTrials

Colorectal NeoplasmsPhase 3VELOURNCT00561470

Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen

A Phase 3 study testing Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in people with Colorectal Neoplasms and Neoplasm Metastasis, run by Sanofi at 221 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Neoplasms, Neoplasm Metastasis
What is being tested?
Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,226 participants
Where
221 sitesin 28 countries
Study dates
Nov 2007to Jun 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically proven adenocarcinoma of the colon or rectum
  • Metastatic disease that is not amenable to potentially curative treatment
  • One and only one prior line of treatment for metastatic disease. This prior line should be an oxaliplatin based chemotherapy (participants who relapse within 6 months of completion of oxaliplatin based adjuvant chemotherapy are eligible)
  • Prior treatment with bevacizumab is permitted.

Who cannot join

  • Prior therapy with irinotecan
  • Eastern Cooperative Oncology Group performance status >2
  • The above information is not intended to contain all considerations relevant to participation in a clinical trial.

Trial locations and contacts

221 sites in 28 countries.

221 sites in 28 countries

United States87 sites

  • Sanofi-Aventis Investigational Site Number 840036

    Albany, New York, 12206

  • Sanofi-Aventis Investigational Site Number 840044

    Albuquerque, New Mexico, 87131

  • Sanofi-Aventis Investigational Site Number 840080

    Anaheim, California, 92801

  • Sanofi-Aventis Investigational Site Number 840043

    Baton Rouge, Louisiana, 70809

  • Sanofi-Aventis Investigational Site Number 840118

    Bethlehem, Pennsylvania, 18015

  • Sanofi-Aventis Investigational Site Number 840119

    Birmingham, Alabama, 35203

  • Sanofi-Aventis Investigational Site Number 840089

    Boynton Beach, Florida, 33435

  • Sanofi-Aventis Investigational Site Number 840035

    Burlington, North Carolina, 27215

  • Sanofi-Aventis Investigational Site Number 840085

    Charleston, South Carolina, 29403

  • Sanofi-Aventis Investigational Site Number 840024

    Charlotte, North Carolina, 28204

  • Sanofi-Aventis Investigational Site Number 840026

    Charlotte, North Carolina, 28262

  • Sanofi-Aventis Investigational Site Number 840087

    Chicago, Illinois, 60616

  • Sanofi-Aventis Investigational Site Number 840098

    Cincinnati, Ohio, 45219

  • Sanofi-Aventis Investigational Site Number 840078

    Corpus Christi, Texas, 78405

  • Sanofi-Aventis Investigational Site Number 840019

    Decatur, Illinois, 62526

  • Sanofi-Aventis Investigational Site Number 840115

    Elk Grove Village, Illinois, 60007

  • Sanofi-Aventis Investigational Site Number 840076

    Fountain Valley, California, 92708

  • Sanofi-Aventis Investigational Site Number 840120

    Fountain Valley, California, 92708

  • Sanofi-Aventis Investigational Site Number 840041

    Gainesville, Florida, 32608

  • Sanofi-Aventis Investigational Site Number 840031

    Gainesville, Florida, 32610

  • Sanofi-Aventis Investigational Site Number 840005

    Goldsboro, North Carolina, 27534

  • Sanofi-Aventis Investigational Site Number 840073

    Greenbrae, California, 94904-2007

  • Sanofi-Aventis Investigational Site Number 840101

    Hayward, California, 94545

  • Sanofi-Aventis Investigational Site Number 840004

    Hendersonville, North Carolina, 28791

  • Sanofi-Aventis Investigational Site Number 840093

    Hot Springs, Arizona, 71913

  • Sanofi-Aventis Investigational Site Number 840072

    Indianapolis, Indiana, 46254

  • Sanofi-Aventis Investigational Site Number 840047

    Indianapolis, Indiana, 46260

  • Sanofi-Aventis Investigational Site Number 840081

    Kansas City, Missouri, 64128

  • Sanofi-Aventis Investigational Site Number 840011

    Kettering, Ohio, 45429

  • Sanofi-Aventis Investigational Site Number 840046

    La Jolla, California, 92037

  • Sanofi-Aventis Investigational Site Number 840094

    Lake Success, New York, 11042

  • Sanofi-Aventis Investigational Site Number 840049

    Las Vegas, Nevada, 89106

  • Sanofi-Aventis Investigational Site Number 840116

    Loma Linda, California, 92354

  • Sanofi-Aventis Investigational Site Number 840048

    Long Beach, California, 90813

  • Sanofi-Aventis Investigational Site Number 840088

    Louisville, Kentucky, 40202

  • Sanofi-Aventis Investigational Site Number 840002

    Marshfield, Wisconsin, 54449

  • Sanofi-Aventis Investigational Site Number 840084

    Metairie, Louisiana, 70006

  • Sanofi-Aventis Investigational Site Number 840122

    Miami, Florida, 33176

  • Sanofi-Aventis Investigational Site Number 840086

    Middletown, Ohio, 45042

  • Sanofi-Aventis Investigational Site Number 840034

    Munster, Indiana, 46321

  • Sanofi-Aventis Investigational Site Number 840074

    Muscle Shoals, Alabama, 35661

  • Sanofi-Aventis Investigational Site Number 840010

    Naperville, Illinois, 60540

  • Sanofi-Aventis Investigational Site Number 840015

    New Orleans, Louisiana, 70121

  • Sanofi-Aventis Investigational Site Number 840014

    Newark, Delaware, 19718

  • Sanofi-Aventis Investigational Site Number 840201

    Oakland, California, 94611

  • Sanofi-Aventis Investigational Site Number 840096

    Paducah, Kentucky, 42003

  • Sanofi-Aventis Investigational Site Number 840082

    Pawtucket, Rhode Island, 02860

  • Sanofi-Aventis Investigational Site Number 840033

    Philadelphia, Pennsylvania, 19107

  • Sanofi-Aventis Investigational Site Number 840012

    Pittsburgh, Pennsylvania, 15212

  • Sanofi-Aventis Investigational Site Number 840053

    Pontiac, Michigan, 48341

  • Sanofi-Aventis Investigational Site Number 840039

    Portland, Oregon, 97227

  • Sanofi-Aventis Investigational Site Number 840113

    Quincy, Illinois, 62301

  • Sanofi-Aventis Investigational Site Number 840070

    Rockville, Maryland, 20850

  • Sanofi-Aventis Investigational Site Number 840901

    Roseville, California, 95678

  • Sanofi-Aventis Investigational Site Number 840042

    Sacramento, California, 95816

  • Sanofi-Aventis Investigational Site Number 840301

    Sacramento, California, 95825

  • Sanofi-Aventis Investigational Site Number 840021

    Saint Louis Park, Minnesota, 55416

  • Sanofi-Aventis Investigational Site Number 840112

    Salinas, California, 93901-3906

  • Sanofi-Aventis Investigational Site Number 840029

    Salisbury, Maryland, 21801

  • Sanofi-Aventis Investigational Site Number 840006

    San Diego, California, 92102

  • Sanofi-Aventis Investigational Site Number 840106

    San Diego, California, 92102

  • Sanofi-Aventis Investigational Site Number 840206

    San Diego, California, 92102

  • Sanofi-Aventis Investigational Site Number 840306

    San Diego, California, 92102

  • Sanofi-Aventis Investigational Site Number 840406

    San Diego, California, 92102

  • Sanofi-Aventis Investigational Site Number 840506

    San Diego, California, 92102

  • Sanofi-Aventis Investigational Site Number 840606

    San Diego, California, 92102

  • Sanofi-Aventis Investigational Site Number 840706

    San Diego, California, 92102

  • Sanofi-Aventis Investigational Site Number 840806

    San Diego, California, 92102

  • Sanofi-Aventis Investigational Site Number 840906

    San Diego, California, 92102

  • Sanofi-Aventis Investigational Site Number 840401

    San Francisco, California, 94115

  • Sanofi-Aventis Investigational Site Number 840601

    San Jose, California, 95119

  • Sanofi-Aventis Investigational Site Number 840501

    Santa Clara, California, 95051

  • Sanofi-Aventis Investigational Site Number 840099

    Seattle, Washington, 98115

  • Sanofi-Aventis Investigational Site Number 840801

    South San Francisco, California, 94080

  • Sanofi-Aventis Investigational Site Number 840037

    Spartanburg, South Carolina, 29303

  • Sanofi-Aventis Investigational Site Number 840052

    St Louis, Missouri, 63104

  • Sanofi-Aventis Investigational Site Number 840114

    St Louis, Missouri, 63136

  • Sanofi-Aventis Investigational Site Number 840071

    Stamford, Connecticut, 06902

  • Sanofi-Aventis Investigational Site Number 840017

    Syracuse, New York, 13210

  • Sanofi-Aventis Investigational Site Number 840097

    Syracuse, New York, 13210

  • Sanofi-Aventis Investigational Site Number 840117

    Temple, Texas, 76508

  • Sanofi-Aventis Investigational Site Number 840079

    The Villages, Florida, 32159

  • Sanofi-Aventis Investigational Site Number 840008

    Toledo, Ohio, 43623

  • Sanofi-Aventis Investigational Site Number 840001

    Vallejo, California, 94589

  • Sanofi-Aventis Investigational Site Number 840701

    Walnut Creek, California, 94596

  • Sanofi-Aventis Investigational Site Number 840075

    Winston-Salem, North Carolina, 27103

  • Sanofi-Aventis Investigational Site Number 840095

    Woonsocket, Rhode Island, 02895

Other trials in United States

United Kingdom10 sites

  • Sanofi-Aventis Investigational Site Number 826001

    Aberdeen, AB25 2ZD

  • Sanofi-Aventis Investigational Site Number 826010

    Bournemouth, BH7 7DW

  • Sanofi-Aventis Investigational Site Number 826009

    Dudley, DY1 2HQ

  • Sanofi-Aventis Investigational Site Number 826008

    London, EC1A 7BE

  • Sanofi-Aventis Investigational Site Number 826004

    London, N18 1QX

  • Sanofi-Aventis Investigational Site Number 826007

    London, SE1 7EH

  • Sanofi-Aventis Investigational Site Number 826011

    London, SW3 6JJ

  • Sanofi-Aventis Investigational Site Number 826002

    Manchester, M20 4BX

  • Sanofi-Aventis Investigational Site Number 826003

    Northwood, HA6 2RN

  • Sanofi-Aventis Investigational Site Number 826005

    Sutton, SM2 5PT

Other trials in United Kingdom

Brazil8 sites

  • Sanofi-Aventis Investigational Site Number 076004

    Porto Alegre, 90035-003

  • Sanofi-Aventis Investigational Site Number 076005

    Porto Alegre, 90110-270

  • Sanofi-Aventis Investigational Site Number 076002

    Porto Alegre, 90430090

  • Sanofi-Aventis Investigational Site Number 076008

    Rio de Janeiro, 20231-050

  • Sanofi-Aventis Investigational Site Number 076003

    Rio de Janeiro, 22260-020

  • Sanofi-Aventis Investigational Site Number 076001

    Santo André, 09050-360

  • Sanofi-Aventis Investigational Site Number 076007

    São Paulo, 01246-000

  • Sanofi-Aventis Investigational Site Number 076006

    São Paulo, 01308050

Other trials in Brazil

Italy8 sites

  • Sanofi-Aventis Investigational Site Number 380007

    Ancona, 60032

  • Sanofi-Aventis Investigational Site Number 380005

    Aviano, 33081

  • Sanofi-Aventis Investigational Site Number 380004

    Candiolo, 10060

  • Sanofi-Aventis Investigational Site Number 380003

    Genova, 16128

  • Sanofi-Aventis Investigational Site Number 380001

    Milan, 20133

  • Sanofi-Aventis Investigational Site Number 380002

    Milan, 20141

  • Sanofi-Aventis Investigational Site Number 380008

    Rozzano, 20089

  • Sanofi-Aventis Investigational Site Number 380006

    San Giovanni Rotondo, 71013

Other trials in Italy

Australia7 sites

  • Sanofi-Aventis Investigational Site Number 036004

    Hornsby, 2077

  • Sanofi-Aventis Investigational Site Number 036001

    Kingswood, 2747

  • Sanofi-Aventis Investigational Site Number 036002

    Kurralta Park, 5037

  • Sanofi-Aventis Investigational Site Number 036005

    Melbourne, 3050

  • Sanofi-Aventis Investigational Site Number 036003

    Melbourne, 3128

  • Sanofi-Aventis Investigational Site Number 036007

    Nedlands, 6009

  • Sanofi-Aventis Investigational Site Number 036006

    Subiaco, 6008

Other trials in Australia

Belgium7 sites

  • Sanofi-Aventis Investigational Site Number 056006

    Bonheiden, 2820

  • Sanofi-Aventis Investigational Site Number 056007

    Brussels, 1000

  • Sanofi-Aventis Investigational Site Number 056002

    Brussels, 1070

  • Sanofi-Aventis Investigational Site Number 056004

    Brussels, 1200

  • Sanofi-Aventis Investigational Site Number 056001

    Ghent, 9000

  • Sanofi-Aventis Investigational Site Number 056005

    Haine-Saint-Paul, 7100

  • Sanofi-Aventis Investigational Site Number 056003

    Leuven, 3000

Other trials in Belgium

Poland7 sites

  • Sanofi-Aventis Investigational Site Number 616005

    Częstochowa, 42-200

  • Sanofi-Aventis Investigational Site Number 616004

    Elblag, 82-300

  • Sanofi-Aventis Investigational Site Number 616007

    Krakow, 31-826

  • Sanofi-Aventis Investigational Site Number 616003

    Lodz, 93-509

  • Sanofi-Aventis Investigational Site Number 616002

    Poznan, 61-485

  • Sanofi-Aventis Investigational Site Number 616006

    Rybnik, 44-200

  • Sanofi-Aventis Investigational Site Number 616001

    Wroclaw, 53-413

Other trials in Poland

Romania7 sites

  • Sanofi-Aventis Investigational Site Number 642004

    Alba Iulia, 510077

  • Sanofi-Aventis Investigational Site Number 642001

    Bucharest, 022328

  • Sanofi-Aventis Investigational Site Number 642002

    Bucharest, 022328

  • Sanofi-Aventis Investigational Site Number 642007

    Bucharest, 050098

  • Sanofi-Aventis Investigational Site Number 642003

    Cluj-Napoca, 400015

  • Sanofi-Aventis Investigational Site Number 642006

    Iași, 700106

  • Sanofi-Aventis Investigational Site Number 642005

    Suceava, 720237

Other trials in Romania

South Africa7 sites

  • Sanofi-Aventis Investigational Site Number 710004

    Cape Town, 7506

  • Sanofi-Aventis Investigational Site Number 710005

    Durban, 4001

  • Sanofi-Aventis Investigational Site Number 710008

    Durban, 4062

  • Sanofi-Aventis Investigational Site Number 710001

    Parktown, 2193

  • Sanofi-Aventis Investigational Site Number 710006

    Port Elizabeth, 6001

  • Sanofi-Aventis Investigational Site Number 710007

    Pretoria, 0001

  • Sanofi-Aventis Investigational Site Number 710003

    Pretoria, 0181

Other trials in South Africa

Germany6 sites

  • Sanofi-Aventis Investigational Site Number 276003

    Aschaffenburg, 63739

  • Sanofi-Aventis Investigational Site Number 276002

    Essen, 45147

  • Sanofi-Aventis Investigational Site Number 276001

    Halle, 06120

  • Sanofi-Aventis Investigational Site Number 276005

    Magdeburg, 39104

  • Sanofi-Aventis Investigational Site Number 276004

    Magdeburg, 39130

  • Sanofi-Aventis Investigational Site Number 276006

    München, 81737

Other trials in Germany

Russia6 sites

  • Sanofi-Aventis Investigational Site Number 643001

    Moscow, 115478

  • Sanofi-Aventis Investigational Site Number 643006

    Moscow, 115478

  • Sanofi-Aventis Investigational Site Number 643002

    Moscow, 129128

  • Sanofi-Aventis Investigational Site Number 643004

    Saint Petersburg, 191104

  • Sanofi-Aventis Investigational Site Number 643003

    Saint Petersburg, 197758

  • Sanofi-Aventis Investigational Site Number 643007

    Saint Petersburg, 197758

Other trials in Russia

Spain6 sites

  • Sanofi-Aventis Investigational Site Number 724002

    Barakaldo, 48903

  • Sanofi-Aventis Investigational Site Number 724005

    Barcelona, 08003

  • Sanofi-Aventis Investigational Site Number 724001

    Barcelona, 08035

  • Sanofi-Aventis Investigational Site Number 724006

    Madrid, 28035

  • Sanofi-Aventis Investigational Site Number 724003

    Madrid, 28041

  • Sanofi-Aventis Investigational Site Number 724007

    Reus, 43201

Other trials in Spain

Chile5 sites

  • Sanofi-Aventis Investigational Site Number 152002

    Santiago, 7510032

  • Sanofi-Aventis Investigational Site Number 152003

    Santiago, 7650635

  • Sanofi-Aventis Investigational Site Number 152001

    Santiago, 8380455

  • Sanofi-Aventis Investigational Site Number 152005

    Santiago, 8380456

  • Sanofi-Aventis Investigational Site Number 152004

    Viña del Mar, 2540364

Other trials in Chile

France5 sites

  • Sanofi-Aventis Investigational Site Number 250002

    Brest, 29200

  • Sanofi-Aventis Investigational Site Number 250004

    Clichy Cx, 92118

  • Sanofi-Aventis Investigational Site Number 250005

    La Roche-sur-Yon, 85925

  • Sanofi-Aventis Investigational Site Number 250001

    Lyon, 69437

  • Sanofi-Aventis Investigational Site Number 250003

    Paris, 75013

Other trials in France

Greece5 sites

  • Sanofi-Aventis Investigational Site Number 300005

    Athens, 11522

  • Sanofi-Aventis Investigational Site Number 300004

    Athens, 11527

  • Sanofi-Aventis Investigational Site Number 300001

    Heraklion, 71110

  • Sanofi-Aventis Investigational Site Number 300002

    Ilion, Athens

  • Sanofi-Aventis Investigational Site Number 300003

    Pátrai, 26500

Other trials in Greece

Netherlands5 sites

  • Sanofi-Aventis Investigational Site Number 528004

    Amsterdam, 1091 HA

  • Sanofi-Aventis Investigational Site Number 528001

    Blaricum, 1261 AN

  • Sanofi-Aventis Investigational Site Number 528005

    Breda, 4819 EV

  • Sanofi-Aventis Investigational Site Number 528002

    Rotterdam, 3007 AC

  • Sanofi-Aventis Investigational Site Number 528003

    Sittard-Geleen, 6162 BG

Other trials in Netherlands

South Korea5 sites

  • Sanofi-Aventis Investigational Site Number 410001

    Goyang, 410-760

  • Sanofi-Aventis Investigational Site Number 410003

    Seoul, 110-744

  • Sanofi-Aventis Investigational Site Number 410005

    Seoul, 120-752

  • Sanofi-Aventis Investigational Site Number 410002

    Seoul, 135-710

  • Sanofi-Aventis Investigational Site Number 410004

    Seoul, 138-736

Other trials in South Korea

Turkey (Türkiye)5 sites

  • Sanofi-Aventis Investigational Site Number 792005

    Adana, 01120

  • Sanofi-Aventis Investigational Site Number 792004

    Ankara, 06100

  • Sanofi-Aventis Investigational Site Number 792001

    Ankara, 06500

  • Sanofi-Aventis Investigational Site Number 792002

    Izmir, 35340

  • Sanofi-Aventis Investigational Site Number 792003

    Kayseri, 38039

Other trials in Turkey (Türkiye)

Argentina4 sites

  • Sanofi-Aventis Investigational Site Number 032003

    Bahía Blanca, 8000

  • Sanofi-Aventis Investigational Site Number 032006

    Buenos Aires, 1426ANZ

  • Sanofi-Aventis Investigational Site Number 032005

    Ciudad de Buenos Aires, C1426BOR

  • Sanofi-Aventis Investigational Site Number 032007

    Salta, 4400

Other trials in Argentina

Ukraine4 sites

  • Sanofi-Aventis Investigational Site Number 804005

    Dnipropetrovsk

  • Sanofi-Aventis Investigational Site Number 804004

    Donetsk, 83092

  • Sanofi-Aventis Investigational Site Number 804006

    Kharkiv, 61037

  • Sanofi-Aventis Investigational Site Number 804002

    Kharkiv, 61070

Other trials in Ukraine

Czechia3 sites

  • Sanofi-Aventis Investigational Site Number 203002

    Brno, 62500

  • Sanofi-Aventis Investigational Site Number 203001

    Brno, 65653

  • Sanofi-Aventis Investigational Site Number 203004

    Prague, 15006

Other trials in Czechia

Norway3 sites

  • Sanofi-Aventis Investigational Site Number 578002

    Bergen, 5021

  • Sanofi-Aventis Investigational Site Number 578001

    Oslo, 0407

  • Sanofi-Aventis Investigational Site Number 578003

    Stavanger, 4011

Other trials in Norway

Sweden3 sites

  • Sanofi-Aventis Investigational Site Number 752002

    Stockholm, 171 76

  • Sanofi-Aventis Investigational Site Number 752003

    Sundsvall, 851 86

  • Sanofi-Aventis Investigational Site Number 752001

    Uppsala, 751 85

Other trials in Sweden

Denmark2 sites

  • Sanofi-Aventis Investigational Site Number 208003

    Aalborg, 9100

  • Sanofi-Aventis Investigational Site Number 208001

    Odense C, 5000

Other trials in Denmark

Estonia2 sites

  • Sanofi-Aventis Investigational Site Number 233002

    Tallinn, 13419

  • Sanofi-Aventis Investigational Site Number 233001

    Tartu, 50406

Other trials in Estonia

New Zealand2 sites

  • Sanofi-Aventis Investigational Site Number 554009

    Auckland, 1023

  • Sanofi-Aventis Investigational Site Number 554010

    Christchurch

Other trials in New Zealand

Austria1 site

  • Sanofi-Aventis Investigational Site Number 040001

    Vienna, 1090

Other trials in Austria

Puerto Rico1 site

  • Sanofi-Aventis Investigational Site Number 630001

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan / 5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen

The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease.

The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.

Read the detailed description

Participants were

  • randomized at baseline (treatment was initiated with 3 days of randomization)
  • administered treatment in cycles of 14-days till a study withdrawal criterion was met
  • followed up 30 days after discontinuation of treatment, and every 8 weeks until death or end of study.

The criteria for discontinuation of study treatment for a participant are:

  • participant (or legal representative) chose to withdraw from treatment
  • the investigator thought that continuation of the study would be detrimental to the participants well-being due to
  • disease progression
  • unacceptable AEs
  • intercurrent illnesses
  • non-compliance to the study protocol
  • participant was lost to follow-up
  • participant was unblinded for the investigational treatment
Being tested
Placebo, Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®), FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Keywords
colorectal cancer, metastatic, anti-angiogenic, irinotecan, 5-FU, FOLFIRI
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    4 mg/kg of sterile aqueous buffered vehicle (pH 6.0) was administered intra venously (IV) over 1 hour on Day 1, every 2 weeks

  • Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)Drug

    4 mg/kg of Aflibercept was administered IV over 1 hour on Day 1, every 2 weeks.

  • FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)Drug

    The FOLFIRI regimen was initiated immediately after Placebo administration on Day 1

    The FOLFIRI regimen included:

    • 180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by:
    • 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by:
    • 5-FU 2400 mg/m² continuous IV infusion over 46-hours

  • FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)Drug

    The FOLFIRI regimen was initiated immediately after Aflibercept administration on Day 1

    The FOLFIRI regimen included:

    • 180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by:
    • 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by:
    • 5-FU 2400 mg/m² continuous IV infusion over 46-hours
Study groups in NCT00561470
Study groupRoleWhat they receive
Placebo/FOLFIRIPlacebo comparatorParticipants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) starting on Day 1 of a 2-week cycle until a treatment discontinuation criterion was met
Receives: Drug: Placebo; Drug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Aflibercept/FOLFIRIExperimentalParticipants with Metastatic Colorectal Cancer administered Aflibercept followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) starting on Day 1 of a 2-week cycle until a treatment discontinuation criterion was met
Receives: Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®); Drug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011).

    OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.

    Measured: From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)

Secondary outcomes (4)

  1. Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)

    PFS was the time interval from the date of randomization to the date of progression, or death from any cause if it occurs before tumor progression is documented. To evaluate disease progression, copies of all tumor imaging sets were systematically collected and assessed by the IRC.

    PFS was analyzed using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.

    The analysis for PFS was performed as planned when 561 deaths (OS events) had occurred.

    Measured: From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months)

  2. Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria

    The overall ORR was the percentage of evaluable participants who achieved complete response [CR] or partial response [PR] according to RECIST criteria version 1.0.

    • CR reflected the disappearance of all tumor lesions (with no new tumors)
    • PR reflected a pre-defined reduction in tumor burden

    Tumors were assessed by the IRC using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 - 6 weeks.

    Measured: From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months)

  3. Number of Participants With Adverse Events (AE)

    All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization.

    The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.

    Measured: From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized

  4. Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay

    Serum samples for immunogenicity assessment were analyzed using a bridging immunoassay to detect ADA. Positive samples in the ADA assay were further analyzed in the NAb assay using a validated, non-quantitative ligand binding assay.

    Measured: Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionFeb 2011
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00561470
Sponsor's protocol ID
EFC10262
Other IDs
EudraCT 2007-000820-42
Acronym
VELOUR
Status last verified
Mar 2012
First submitted
20 Nov 2007
Last updated
28 Sep 2012
Data monitoring committee
Yes

Publications

  • Pu T, Peddle AM, Wirapati P, Tsantoulis P, Wu Q, Hong Y, Samuel L, Desai J, Riener M, Saridaki Z, Cunningham D, Tejpar S. Exploratory biomarker analysis of RAS/BRAF somatic mutations and gene expression signatures for predicting treatment effects of aflibercept in the velour trial. NPJ Precis Oncol. 2026 Jan 13;10(1):50. doi: 10.1038/s41698-025-01253-5.

    PubMed 41530374

  • Wazan LE, Widhibrata A, Liu GS. Soluble FLT-1 in angiogenesis: pathophysiological roles and therapeutic implications. Angiogenesis. 2024 Nov;27(4):641-661. doi: 10.1007/s10456-024-09942-8. Epub 2024 Aug 29.

    PubMed 39207600

  • Lu L, Dercle L, Zhao B, Schwartz LH. Deep learning for the prediction of early on-treatment response in metastatic colorectal cancer from serial medical imaging. Nat Commun. 2021 Nov 17;12(1):6654. doi: 10.1038/s41467-021-26990-6.

    PubMed 34789774

  • Chau I, Fakih M, Garcia-Alfonso P, Linke Z, Ruiz Casado A, Marques EP, Picard P, Celanovic M, Cartwright T. Safety and Effectiveness of Aflibercept + Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) for the Treatment of Patients with Metastatic Colorectal Cancer (mCRC) in Current Clinical Practice: OZONE Study. Cancers (Basel). 2020 Mar 11;12(3):657. doi: 10.3390/cancers12030657.

    PubMed 32168980

  • Ruff P, Van Cutsem E, Lakomy R, Prausova J, van Hazel GA, Moiseyenko VM, Soussan-Lazard K, Dochy E, Magherini E, Macarulla T, Papamichael D. Observed benefit and safety of aflibercept in elderly patients with metastatic colorectal cancer: An age-based analysis from the randomized placebo-controlled phase III VELOUR trial. J Geriatr Oncol. 2018 Jan;9(1):32-39. doi: 10.1016/j.jgo.2017.07.010. Epub 2017 Aug 12.

    PubMed 28807738

  • Stanel SC, Sjoberg J, Salmonson T, Foggi P, Caleno M, Melchiorri D, Gravanis I, Tzogani K, Pignatti F. European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer. ESMO Open. 2017 May 2;2(2):e000190. doi: 10.1136/esmoopen-2017-000190. eCollection 2017.

    PubMed 28761750

  • Van Cutsem E, Joulain F, Hoff PM, Mitchell E, Ruff P, Lakomy R, Prausova J, Moiseyenko VM, van Hazel G, Cunningham D, Arnold D, Schmoll HJ, Ten Tije AJ, McKendrick J, Kroning H, Humblet Y, Gravalos C, Le-Guennec S, Andria M, Dochy E, Vishwanath RL, Macarulla T, Tabernero J. Aflibercept Plus FOLFIRI vs. Placebo Plus FOLFIRI in Second-Line Metastatic Colorectal Cancer: a Post Hoc Analysis of Survival from the Phase III VELOUR Study Subsequent to Exclusion of Patients who had Recurrence During or Within 6 Months of Completing Adjuvant Oxaliplatin-Based Therapy. Target Oncol. 2016 Jun;11(3):383-400. doi: 10.1007/s11523-015-0402-9.

    PubMed 26706237

  • Tabernero J, Van Cutsem E, Lakomy R, Prausova J, Ruff P, van Hazel GA, Moiseyenko VM, Ferry DR, McKendrick JJ, Soussan-Lazard K, Chevalier S, Allegra CJ. Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial. Eur J Cancer. 2014 Jan;50(2):320-31. doi: 10.1016/j.ejca.2013.09.013. Epub 2013 Oct 16.

    PubMed 24140268

  • Van Cutsem E, Tabernero J, Lakomy R, Prenen H, Prausova J, Macarulla T, Ruff P, van Hazel GA, Moiseyenko V, Ferry D, McKendrick J, Polikoff J, Tellier A, Castan R, Allegra C. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol. 2012 Oct 1;30(28):3499-506. doi: 10.1200/JCO.2012.42.8201. Epub 2012 Sep 4.

    PubMed 22949147

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in people with Colorectal Neoplasms and Neoplasm Metastasis, run by Sanofi at 221 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 221 sites in United States, United Kingdom, Brazil, Italy, Australia and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00561470, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2012.

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