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 (VELOUR)

September 27, 2012 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

1226

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahia Blanca, Argentina, 8000
        • Sanofi-Aventis Investigational Site Number 032003
      • Buenos Aires, Argentina, 1426ANZ
        • Sanofi-Aventis Investigational Site Number 032006
      • Ciudad De Buenos Aires, Argentina, C1426BOR
        • Sanofi-Aventis Investigational Site Number 032005
      • Salta, Argentina, 4400
        • Sanofi-Aventis Investigational Site Number 032007
  • Australia
      • Hornsby, Australia, 2077
        • Sanofi-Aventis Investigational Site Number 036004
      • Kingswood, Australia, 2747
        • Sanofi-Aventis Investigational Site Number 036001
      • Kurralta Park, Australia, 5037
        • Sanofi-Aventis Investigational Site Number 036002
      • Melbourne, Australia, 3050
        • Sanofi-Aventis Investigational Site Number 036005
      • Melbourne, Australia, 3128
        • Sanofi-Aventis Investigational Site Number 036003
      • Nedlands, Australia, 6009
        • Sanofi-Aventis Investigational Site Number 036007
      • Subiaco, Australia, 6008
        • Sanofi-Aventis Investigational Site Number 036006
  • Austria
      • Wien, Austria, 1090
        • Sanofi-Aventis Investigational Site Number 040001
  • Belgium
      • Bonheiden, Belgium, 2820
        • Sanofi-Aventis Investigational Site Number 056006
      • Bruxelles, Belgium, 1000
        • Sanofi-Aventis Investigational Site Number 056007
      • Bruxelles, Belgium, 1070
        • Sanofi-Aventis Investigational Site Number 056002
      • Bruxelles, Belgium, 1200
        • Sanofi-Aventis Investigational Site Number 056004
      • Gent, Belgium, 9000
        • Sanofi-Aventis Investigational Site Number 056001
      • Haine-Saint-Paul, Belgium, 7100
        • Sanofi-Aventis Investigational Site Number 056005
      • Leuven, Belgium, 3000
        • Sanofi-Aventis Investigational Site Number 056003
  • Brazil
      • Porto Alegre, Brazil, 90035-003
        • Sanofi-Aventis Investigational Site Number 076004
      • Porto Alegre, Brazil, 90110-270
        • Sanofi-Aventis Investigational Site Number 076005
      • Porto Alegre, Brazil, 90430090
        • Sanofi-Aventis Investigational Site Number 076002
      • Rio De Janeiro, Brazil, 20231-050
        • Sanofi-Aventis Investigational Site Number 076008
      • Rio De Janeiro, Brazil, 22260-020
        • Sanofi-Aventis Investigational Site Number 076003
      • Santo Andre, Brazil, 09050-360
        • Sanofi-Aventis Investigational Site Number 076001
      • Sao Paulo, Brazil, 01246-000
        • Sanofi-Aventis Investigational Site Number 076007
      • Sao Paulo, Brazil, 01308050
        • Sanofi-Aventis Investigational Site Number 076006
  • Chile
      • Santiago, Chile, 7510032
        • Sanofi-Aventis Investigational Site Number 152002
      • Santiago, Chile, 7650635
        • Sanofi-Aventis Investigational Site Number 152003
      • Santiago, Chile, 8380455
        • Sanofi-Aventis Investigational Site Number 152001
      • Santiago, Chile, 8380456
        • Sanofi-Aventis Investigational Site Number 152005
      • Viña Del Mar, Chile, 2540364
        • Sanofi-Aventis Investigational Site Number 152004
  • Czech Republic
      • Brno, Czech Republic, 62500
        • Sanofi-Aventis Investigational Site Number 203002
      • Brno, Czech Republic, 65653
        • Sanofi-Aventis Investigational Site Number 203001
      • Praha 5, Czech Republic, 15006
        • Sanofi-Aventis Investigational Site Number 203004
  • Denmark
      • Odense C, Denmark, 5000
        • Sanofi-Aventis Investigational Site Number 208001
      • Ålborg, Denmark, 9100
        • Sanofi-Aventis Investigational Site Number 208003
  • Estonia
      • Tallinn, Estonia, 13419
        • Sanofi-Aventis Investigational Site Number 233002
      • Tartu, Estonia, 50406
        • Sanofi-Aventis Investigational Site Number 233001
  • France
      • Brest, France, 29200
        • Sanofi-Aventis Investigational Site Number 250002
      • Clichy Cx, France, 92118
        • Sanofi-Aventis Investigational Site Number 250004
      • La Roche Sur Yon, France, 85925
        • Sanofi-Aventis Investigational Site Number 250005
      • Lyon Cedex 03, France, 69437
        • Sanofi-Aventis Investigational Site Number 250001
      • Paris, France, 75013
        • Sanofi-Aventis Investigational Site Number 250003
  • Germany
      • Aschaffenburg, Germany, 63739
        • Sanofi-Aventis Investigational Site Number 276003
      • Essen, Germany, 45147
        • Sanofi-Aventis Investigational Site Number 276002
      • Halle / Saale, Germany, 06120
        • Sanofi-Aventis Investigational Site Number 276001
      • Magdeburg, Germany, 39104
        • Sanofi-Aventis Investigational Site Number 276005
      • Magdeburg, Germany, 39130
        • Sanofi-Aventis Investigational Site Number 276004
      • München, Germany, 81737
        • Sanofi-Aventis Investigational Site Number 276006
  • Greece
      • Athens, Greece, 11522
        • Sanofi-Aventis Investigational Site Number 300005
      • Athens, Greece, 11527
        • Sanofi-Aventis Investigational Site Number 300004
      • Heraklion, Greece, 71110
        • Sanofi-Aventis Investigational Site Number 300001
      • Ilion, Athens, Greece
        • Sanofi-Aventis Investigational Site Number 300002
      • Patras, Greece, 26500
        • Sanofi-Aventis Investigational Site Number 300003
  • Italy
      • Ancona, Italy, 60032
        • Sanofi-Aventis Investigational Site Number 380007
      • Aviano, Italy, 33081
        • Sanofi-Aventis Investigational Site Number 380005
      • Candiolo, Italy, 10060
        • Sanofi-Aventis Investigational Site Number 380004
      • Genova, Italy, 16128
        • Sanofi-Aventis Investigational Site Number 380003
      • Milano, Italy, 20133
        • Sanofi-Aventis Investigational Site Number 380001
      • Milano, Italy, 20141
        • Sanofi-Aventis Investigational Site Number 380002
      • Rozzano, Italy, 20089
        • Sanofi-Aventis Investigational Site Number 380008
      • San Giovanni Rotondo, Italy, 71013
        • Sanofi-Aventis Investigational Site Number 380006
  • Korea, Republic of
      • Goyang, Korea, Republic of, 410-760
        • Sanofi-Aventis Investigational Site Number 410001
      • Seoul, Korea, Republic of, 110-744
        • Sanofi-Aventis Investigational Site Number 410003
      • Seoul, Korea, Republic of, 120-752
        • Sanofi-Aventis Investigational Site Number 410005
      • Seoul, Korea, Republic of, 135-710
        • Sanofi-Aventis Investigational Site Number 410002
      • Seoul, Korea, Republic of, 138-736
        • Sanofi-Aventis Investigational Site Number 410004
  • Netherlands
      • Amsterdam, Netherlands, 1091 HA
        • Sanofi-Aventis Investigational Site Number 528004
      • Blaricum, Netherlands, 1261 AN
        • Sanofi-Aventis Investigational Site Number 528001
      • Breda, Netherlands, 4819 EV
        • Sanofi-Aventis Investigational Site Number 528005
      • Rotterdam, Netherlands, 3007 AC
        • Sanofi-Aventis Investigational Site Number 528002
      • Sittard-Geleen, Netherlands, 6162 BG
        • Sanofi-Aventis Investigational Site Number 528003
  • New Zealand
      • Auckland, New Zealand, 1023
        • Sanofi-Aventis Investigational Site Number 554009
      • Christchurch, New Zealand
        • Sanofi-Aventis Investigational Site Number 554010
  • Norway
      • Bergen, Norway, 5021
        • Sanofi-Aventis Investigational Site Number 578002
      • Oslo, Norway, 0407
        • Sanofi-Aventis Investigational Site Number 578001
      • Stavanger, Norway, 4011
        • Sanofi-Aventis Investigational Site Number 578003
  • Poland
      • Czestochowa, Poland, 42-200
        • Sanofi-Aventis Investigational Site Number 616005
      • Elblag, Poland, 82-300
        • Sanofi-Aventis Investigational Site Number 616004
      • Krakow, Poland, 31-826
        • Sanofi-Aventis Investigational Site Number 616007
      • Lodz, Poland, 93-509
        • Sanofi-Aventis Investigational Site Number 616003
      • Poznan, Poland, 61-485
        • Sanofi-Aventis Investigational Site Number 616002
      • Rybnik, Poland, 44-200
        • Sanofi-Aventis Investigational Site Number 616006
      • Wroclaw, Poland, 53-413
        • Sanofi-Aventis Investigational Site Number 616001
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Sanofi-Aventis Investigational Site Number 630001
  • Romania
      • Alba Iulia, Romania, 510077
        • Sanofi-Aventis Investigational Site Number 642004
      • Bucharest, Romania, 050098
        • Sanofi-Aventis Investigational Site Number 642007
      • Bucuresti, Romania, 022328
        • Sanofi-Aventis Investigational Site Number 642001
      • Bucuresti, Romania, 022328
        • Sanofi-Aventis Investigational Site Number 642002
      • Cluj Napoca, Romania, 400015
        • Sanofi-Aventis Investigational Site Number 642003
      • Iasi, Romania, 700106
        • Sanofi-Aventis Investigational Site Number 642006
      • Suceava, Romania, 720237
        • Sanofi-Aventis Investigational Site Number 642005
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Sanofi-Aventis Investigational Site Number 643001
      • Moscow, Russian Federation, 115478
        • Sanofi-Aventis Investigational Site Number 643006
      • Moscow, Russian Federation, 129128
        • Sanofi-Aventis Investigational Site Number 643002
      • Saint-Petersburg, Russian Federation, 197758
        • Sanofi-Aventis Investigational Site Number 643003
      • St-Petersburg, Russian Federation, 191104
        • Sanofi-Aventis Investigational Site Number 643004
      • St-Petersburg, Russian Federation, 197758
        • Sanofi-Aventis Investigational Site Number 643007
  • South Africa
      • Cape Town, South Africa, 7506
        • Sanofi-Aventis Investigational Site Number 710004
      • Durban, South Africa, 4001
        • Sanofi-Aventis Investigational Site Number 710005
      • Durban, South Africa, 4062
        • Sanofi-Aventis Investigational Site Number 710008
      • Parktown, South Africa, 2193
        • Sanofi-Aventis Investigational Site Number 710001
      • Port Elizabeth, South Africa, 6001
        • Sanofi-Aventis Investigational Site Number 710006
      • Pretoria, South Africa, 0181
        • Sanofi-Aventis Investigational Site Number 710003
      • Pretoria, South Africa, 0001
        • Sanofi-Aventis Investigational Site Number 710007
  • Spain
      • Barakaldo, Spain, 48903
        • Sanofi-Aventis Investigational Site Number 724002
      • Barcelona, Spain, 08035
        • Sanofi-Aventis Investigational Site Number 724001
      • Barcelona, Spain, 08003
        • Sanofi-Aventis Investigational Site Number 724005
      • Madrid, Spain, 28035
        • Sanofi-Aventis Investigational Site Number 724006
      • Madrid, Spain, 28041
        • Sanofi-Aventis Investigational Site Number 724003
      • Reus, Spain, 43201
        • Sanofi-Aventis Investigational Site Number 724007
  • Sweden
      • Stockholm, Sweden, 171 76
        • Sanofi-Aventis Investigational Site Number 752002
      • Sundsvall, Sweden, 851 86
        • Sanofi-Aventis Investigational Site Number 752003
      • Uppsala, Sweden, 751 85
        • Sanofi-Aventis Investigational Site Number 752001
  • Turkey
      • Adana, Turkey, 01120
        • Sanofi-Aventis Investigational Site Number 792005
      • Ankara, Turkey, 06100
        • Sanofi-Aventis Investigational Site Number 792004
      • Ankara, Turkey, 06500
        • Sanofi-Aventis Investigational Site Number 792001
      • Izmir, Turkey, 35340
        • Sanofi-Aventis Investigational Site Number 792002
      • Kayseri, Turkey, 38039
        • Sanofi-Aventis Investigational Site Number 792003
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Sanofi-Aventis Investigational Site Number 804005
      • Donetsk, Ukraine, 83092
        • Sanofi-Aventis Investigational Site Number 804004
      • Kharkiv, Ukraine, 61037
        • Sanofi-Aventis Investigational Site Number 804006
      • Kharkov, Ukraine, 61070
        • Sanofi-Aventis Investigational Site Number 804002
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZD
        • Sanofi-Aventis Investigational Site Number 826001
      • Bournemouth, United Kingdom, BH7 7DW
        • Sanofi-Aventis Investigational Site Number 826010
      • Dudley, United Kingdom, DY1 2HQ
        • Sanofi-Aventis Investigational Site Number 826009
      • London, United Kingdom, EC1A 7BE
        • Sanofi-Aventis Investigational Site Number 826008
      • London, United Kingdom, N18 1QX
        • Sanofi-Aventis Investigational Site Number 826004
      • London, United Kingdom, SE1 7EH
        • Sanofi-Aventis Investigational Site Number 826007
      • London, United Kingdom, SW3 6JJ
        • Sanofi-Aventis Investigational Site Number 826011
      • Manchester, United Kingdom, M20 4BX
        • Sanofi-Aventis Investigational Site Number 826002
      • Northwood, United Kingdom, HA6 2RN
        • Sanofi-Aventis Investigational Site Number 826003
      • Sutton, United Kingdom, SM2 5PT
        • Sanofi-Aventis Investigational Site Number 826005
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35203
        • Sanofi-Aventis Investigational Site Number 840119
      • Muscle Shoals, Alabama, United States, 35661
        • Sanofi-Aventis Investigational Site Number 840074
    • Arizona
      • Hot Springs, Arizona, United States, 71913
        • Sanofi-Aventis Investigational Site Number 840093
    • California
      • Anaheim, California, United States, 92801
        • Sanofi-Aventis Investigational Site Number 840080
      • Fountain Valley, California, United States, 92708
        • Sanofi-Aventis Investigational Site Number 840076
      • Fountain Valley, California, United States, 92708
        • Sanofi-Aventis Investigational Site Number 840120
      • Greenbrae, California, United States, 94904-2007
        • Sanofi-Aventis Investigational Site Number 840073
      • Hayward, California, United States, 94545
        • Sanofi-Aventis Investigational Site Number 840101
      • La Jolla, California, United States, 92037
        • Sanofi-Aventis Investigational Site Number 840046
      • Loma Linda, California, United States, 92354
        • Sanofi-Aventis Investigational Site Number 840116
      • Long Beach, California, United States, 90813
        • Sanofi-Aventis Investigational Site Number 840048
      • Oakland, California, United States, 94611
        • Sanofi-Aventis Investigational Site Number 840201
      • Roseville, California, United States, 95678
        • Sanofi-Aventis Investigational Site Number 840901
      • Sacramento, California, United States, 95816
        • Sanofi-Aventis Investigational Site Number 840042
      • Sacramento, California, United States, 95825
        • Sanofi-Aventis Investigational Site Number 840301
      • Salinas, California, United States, 93901-3906
        • Sanofi-Aventis Investigational Site Number 840112
      • San Diego, California, United States, 92102
        • Sanofi-Aventis Investigational Site Number 840006
      • San Diego, California, United States, 92102
        • Sanofi-Aventis Investigational Site Number 840106
      • San Diego, California, United States, 92102
        • Sanofi-Aventis Investigational Site Number 840206
      • San Diego, California, United States, 92102
        • Sanofi-Aventis Investigational Site Number 840306
      • San Diego, California, United States, 92102
        • Sanofi-Aventis Investigational Site Number 840406
      • San Diego, California, United States, 92102
        • Sanofi-Aventis Investigational Site Number 840506
      • San Diego, California, United States, 92102
        • Sanofi-Aventis Investigational Site Number 840606
      • San Diego, California, United States, 92102
        • Sanofi-Aventis Investigational Site Number 840706
      • San Diego, California, United States, 92102
        • Sanofi-Aventis Investigational Site Number 840806
      • San Diego, California, United States, 92102
        • Sanofi-Aventis Investigational Site Number 840906
      • San Francisco, California, United States, 94115
        • Sanofi-Aventis Investigational Site Number 840401
      • San Jose, California, United States, 95119
        • Sanofi-Aventis Investigational Site Number 840601
      • Santa Clara, California, United States, 95051
        • Sanofi-Aventis Investigational Site Number 840501
      • South San Francisco, California, United States, 94080
        • Sanofi-Aventis Investigational Site Number 840801
      • Vallejo, California, United States, 94589
        • Sanofi-Aventis Investigational Site Number 840001
      • Walnut Creek, California, United States, 94596
        • Sanofi-Aventis Investigational Site Number 840701
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • Sanofi-Aventis Investigational Site Number 840071
    • Delaware
      • Newark, Delaware, United States, 19718
        • Sanofi-Aventis Investigational Site Number 840014
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Sanofi-Aventis Investigational Site Number 840089
      • Gainesville, Florida, United States, 32608
        • Sanofi-Aventis Investigational Site Number 840041
      • Gainesville, Florida, United States, 32610
        • Sanofi-Aventis Investigational Site Number 840031
      • Miami, Florida, United States, 33176
        • Sanofi-Aventis Investigational Site Number 840122
      • The Villages, Florida, United States, 32159
        • Sanofi-Aventis Investigational Site Number 840079
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Sanofi-Aventis Investigational Site Number 840087
      • Decatur, Illinois, United States, 62526
        • Sanofi-Aventis Investigational Site Number 840019
      • Elk Grove Village, Illinois, United States, 60007
        • Sanofi-Aventis Investigational Site Number 840115
      • Naperville, Illinois, United States, 60540
        • Sanofi-Aventis Investigational Site Number 840010
      • Quincy, Illinois, United States, 62301
        • Sanofi-Aventis Investigational Site Number 840113
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Sanofi-Aventis Investigational Site Number 840072
      • Indianapolis, Indiana, United States, 46260
        • Sanofi-Aventis Investigational Site Number 840047
      • Munster, Indiana, United States, 46321
        • Sanofi-Aventis Investigational Site Number 840034
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Sanofi-Aventis Investigational Site Number 840088
      • Paducah, Kentucky, United States, 42003
        • Sanofi-Aventis Investigational Site Number 840096
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Sanofi-Aventis Investigational Site Number 840043
      • Metairie, Louisiana, United States, 70006
        • Sanofi-Aventis Investigational Site Number 840084
      • New Orleans, Louisiana, United States, 70121
        • Sanofi-Aventis Investigational Site Number 840015
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Sanofi-Aventis Investigational Site Number 840070
      • Salisbury, Maryland, United States, 21801
        • Sanofi-Aventis Investigational Site Number 840029
    • Michigan
      • Pontiac, Michigan, United States, 48341
        • Sanofi-Aventis Investigational Site Number 840053
    • Minnesota
      • St Louis Park, Minnesota, United States, 55416
        • Sanofi-Aventis Investigational Site Number 840021
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Sanofi-Aventis Investigational Site Number 840081
      • St Louis, Missouri, United States, 63104
        • Sanofi-Aventis Investigational Site Number 840052
      • St. Louis, Missouri, United States, 63136
        • Sanofi-Aventis Investigational Site Number 840114
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Sanofi-Aventis Investigational Site Number 840049
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Sanofi-Aventis Investigational Site Number 840044
    • New York
      • Albany, New York, United States, 12206
        • Sanofi-Aventis Investigational Site Number 840036
      • Lake Success, New York, United States, 11042
        • Sanofi-Aventis Investigational Site Number 840094
      • Syracuse, New York, United States, 13210
        • Sanofi-Aventis Investigational Site Number 840017
      • Syracuse, New York, United States, 13210
        • Sanofi-Aventis Investigational Site Number 840097
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Sanofi-Aventis Investigational Site Number 840035
      • Charlotte, North Carolina, United States, 28204
        • Sanofi-Aventis Investigational Site Number 840024
      • Charlotte, North Carolina, United States, 28262
        • Sanofi-Aventis Investigational Site Number 840026
      • Goldsboro, North Carolina, United States, 27534
        • Sanofi-Aventis Investigational Site Number 840005
      • Hendersonville, North Carolina, United States, 28791
        • Sanofi-Aventis Investigational Site Number 840004
      • Winston-Salem, North Carolina, United States, 27103
        • Sanofi-Aventis Investigational Site Number 840075
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Sanofi-Aventis Investigational Site Number 840098
      • Kettering, Ohio, United States, 45429
        • Sanofi-Aventis Investigational Site Number 840011
      • Middletown, Ohio, United States, 45042
        • Sanofi-Aventis Investigational Site Number 840086
      • Toledo, Ohio, United States, 43623
        • Sanofi-Aventis Investigational Site Number 840008
    • Oregon
      • Portland, Oregon, United States, 97227
        • Sanofi-Aventis Investigational Site Number 840039
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Sanofi-Aventis Investigational Site Number 840118
      • Philadelphia, Pennsylvania, United States, 19107
        • Sanofi-Aventis Investigational Site Number 840033
      • Pittsburgh, Pennsylvania, United States, 15212
        • Sanofi-Aventis Investigational Site Number 840012
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Sanofi-Aventis Investigational Site Number 840082
      • Woonsocket, Rhode Island, United States, 02895
        • Sanofi-Aventis Investigational Site Number 840095
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Sanofi-Aventis Investigational Site Number 840085
      • Spartanburg, South Carolina, United States, 29303
        • Sanofi-Aventis Investigational Site Number 840037
    • Texas
      • Corpus Christi, Texas, United States, 78405
        • Sanofi-Aventis Investigational Site Number 840078
      • Temple, Texas, United States, 76508
        • Sanofi-Aventis Investigational Site Number 840117
    • Washington
      • Seattle, Washington, United States, 98115
        • Sanofi-Aventis Investigational Site Number 840099
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Sanofi-Aventis Investigational Site Number 840002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Participants who met the following main selection criteria were included in the study.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo/FOLFIRI
Participants 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
Drug: Placebo
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
Drug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

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

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
Experimental: Aflibercept/FOLFIRI
Participants 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
Drug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

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

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
Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
4 mg/kg of Aflibercept was administered IV over 1 hour on Day 1, every 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)
Time Frame: From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months)

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.
From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months)
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
Time Frame: From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months)

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.
From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months)
Number of Participants With Adverse Events (AE)
Time Frame: From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized

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.
From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized
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
Time Frame: Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo
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.
Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals
NSABP Foundation Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 20, 2007

First Posted (Estimate)

November 21, 2007

Study Record Updates

Last Update Posted (Estimate)

September 28, 2012

Last Update Submitted That Met QC Criteria

September 27, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC10262
  • EudraCT 2007-000820-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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