Clinical trial NCT00561470: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Neoplasms
Neoplasm Metastasis
Keywords: colorectal cancer
metastatic
anti-angiogenic
irinotecan
5-FU
FOLFIRI
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
name: NSABP Foundation Inc
First posted: 2007-11-21
Enrollment: 1226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)
Secondary outcomes:
measure: Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)
timeFrame: From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months)
measure: 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
timeFrame: From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months)
measure: Number of Participants With Adverse Events (AE)
timeFrame: From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized
measure: 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
timeFrame: Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sanofi-Aventis Investigational Site Number 840119
state: Alabama
city: Muscle Shoals
country: United States
facility: Sanofi-Aventis Investigational Site Number 840074
state: Alabama
city: Hot Springs
country: United States
facility: Sanofi-Aventis Investigational Site Number 840093
state: Arizona
city: Anaheim
country: United States
facility: Sanofi-Aventis Investigational Site Number 840080
state: California
city: Fountain Valley
country: United States
facility: Sanofi-Aventis Investigational Site Number 840076
state: California
city: Fountain Valley
country: United States
facility: Sanofi-Aventis Investigational Site Number 840120
state: California
city: Greenbrae
country: United States
facility: Sanofi-Aventis Investigational Site Number 840073
state: California
city: Hayward
country: United States
facility: Sanofi-Aventis Investigational Site Number 840101
state: California
city: La Jolla
country: United States
facility: Sanofi-Aventis Investigational Site Number 840046
state: California
city: Loma Linda
country: United States
facility: Sanofi-Aventis Investigational Site Number 840116
state: California
city: Long Beach
country: United States
facility: Sanofi-Aventis Investigational Site Number 840048
state: California
city: Oakland
country: United States
facility: Sanofi-Aventis Investigational Site Number 840201
state: California
city: Roseville
country: United States
facility: Sanofi-Aventis Investigational Site Number 840901
state: California
city: Sacramento
country: United States
facility: Sanofi-Aventis Investigational Site Number 840042
state: California
city: Sacramento
country: United States
facility: Sanofi-Aventis Investigational Site Number 840301
state: California
city: Salinas
country: United States
facility: Sanofi-Aventis Investigational Site Number 840112
state: California
city: San Diego
country: United States
facility: Sanofi-Aventis Investigational Site Number 840006
state: California
city: San Diego
country: United States
facility: Sanofi-Aventis Investigational Site Number 840106
state: California
city: San Diego
country: United States
facility: Sanofi-Aventis Investigational Site Number 840206
state: California
city: San Diego
country: United States
facility: Sanofi-Aventis Investigational Site Number 840306
state: California
city: San Diego
country: United States
facility: Sanofi-Aventis Investigational Site Number 840406
state: California
city: San Diego
country: United States
facility: Sanofi-Aventis Investigational Site Number 840506
state: California
city: San Diego
country: United States
facility: Sanofi-Aventis Investigational Site Number 840606
state: California
city: San Diego
country: United States
facility: Sanofi-Aventis Investigational Site Number 840706
state: California
city: San Diego
country: United States
facility: Sanofi-Aventis Investigational Site Number 840806
state: California
city: San Diego
country: United States
facility: Sanofi-Aventis Investigational Site Number 840906
state: California
city: San Francisco
country: United States
facility: Sanofi-Aventis Investigational Site Number 840401
state: California
city: San Jose
country: United States
facility: Sanofi-Aventis Investigational Site Number 840601
state: California
city: Santa Clara
country: United States
facility: Sanofi-Aventis Investigational Site Number 840501
state: California
city: South San Francisco
country: United States
facility: Sanofi-Aventis Investigational Site Number 840801
state: California
city: Vallejo
country: United States
facility: Sanofi-Aventis Investigational Site Number 840001
state: California
city: Walnut Creek
country: United States
facility: Sanofi-Aventis Investigational Site Number 840701
state: California
city: Stamford
country: United States
facility: Sanofi-Aventis Investigational Site Number 840071
state: Connecticut
city: Newark
country: United States
facility: Sanofi-Aventis Investigational Site Number 840014
state: Delaware
city: Boynton Beach
country: United States
facility: Sanofi-Aventis Investigational Site Number 840089
state: Florida
city: Gainesville
country: United States
facility: Sanofi-Aventis Investigational Site Number 840041
state: Florida
city: Gainesville
country: United States
facility: Sanofi-Aventis Investigational Site Number 840031
state: Florida
city: Miami
country: United States
facility: Sanofi-Aventis Investigational Site Number 840122
state: Florida
city: The Villages
country: United States
facility: Sanofi-Aventis Investigational Site Number 840079
state: Florida
city: Chicago
country: United States
facility: Sanofi-Aventis Investigational Site Number 840087
state: Illinois
city: Decatur
country: United States
facility: Sanofi-Aventis Investigational Site Number 840019
state: Illinois
city: Elk Grove Village
country: United States
facility: Sanofi-Aventis Investigational Site Number 840115
state: Illinois
city: Naperville
country: United States
facility: Sanofi-Aventis Investigational Site Number 840010
state: Illinois
city: Quincy
country: United States
facility: Sanofi-Aventis Investigational Site Number 840113
state: Illinois
city: Indianapolis
country: United States
facility: Sanofi-Aventis Investigational Site Number 840072
state: Indiana
city: Indianapolis
country: United States
facility: Sanofi-Aventis Investigational Site Number 840047
state: Indiana
city: Munster
country: United States
facility: Sanofi-Aventis Investigational Site Number 840034
state: Indiana
city: Louisville
country: United States
facility: Sanofi-Aventis Investigational Site Number 840088
state: Kentucky
city: Paducah
country: United States
facility: Sanofi-Aventis Investigational Site Number 840096
state: Kentucky
city: Baton Rouge
country: United States
facility: Sanofi-Aventis Investigational Site Number 840043
state: Louisiana
city: Metairie
country: United States
facility: Sanofi-Aventis Investigational Site Number 840084
state: Louisiana
city: New Orleans
country: United States
facility: Sanofi-Aventis Investigational Site Number 840015
state: Louisiana
city: Rockville
country: United States
facility: Sanofi-Aventis Investigational Site Number 840070
state: Maryland
city: Salisbury
country: United States
facility: Sanofi-Aventis Investigational Site Number 840029
state: Maryland
city: Pontiac
country: United States
facility: Sanofi-Aventis Investigational Site Number 840053
state: Michigan
city: St Louis Park
country: United States
facility: Sanofi-Aventis Investigational Site Number 840021
state: Minnesota
city: Kansas City
country: United States
facility: Sanofi-Aventis Investigational Site Number 840081
state: Missouri
city: St Louis
country: United States
facility: Sanofi-Aventis Investigational Site Number 840052
state: Missouri
city: St. Louis
country: United States
facility: Sanofi-Aventis Investigational Site Number 840114
state: Missouri
city: Las Vegas
country: United States
facility: Sanofi-Aventis Investigational Site Number 840049
state: Nevada
city: Albuquerque
country: United States
facility: Sanofi-Aventis Investigational Site Number 840044
state: New Mexico
city: Albany
country: United States
facility: Sanofi-Aventis Investigational Site Number 840036
state: New York
city: Lake Success
country: United States
facility: Sanofi-Aventis Investigational Site Number 840094
state: New York
city: Syracuse
country: United States
facility: Sanofi-Aventis Investigational Site Number 840017
state: New York
city: Syracuse
country: United States
facility: Sanofi-Aventis Investigational Site Number 840097
state: New York
city: Burlington
country: United States
facility: Sanofi-Aventis Investigational Site Number 840035
state: North Carolina
city: Charlotte
country: United States
facility: Sanofi-Aventis Investigational Site Number 840024
state: North Carolina
city: Charlotte
country: United States
facility: Sanofi-Aventis Investigational Site Number 840026
state: North Carolina
city: Goldsboro
country: United States
facility: Sanofi-Aventis Investigational Site Number 840005
state: North Carolina
city: Hendersonville
country: United States
facility: Sanofi-Aventis Investigational Site Number 840004
state: North Carolina
city: Winston-Salem
country: United States
facility: Sanofi-Aventis Investigational Site Number 840075
state: North Carolina
city: Cincinnati
country: United States
facility: Sanofi-Aventis Investigational Site Number 840098
state: Ohio
city: Kettering
country: United States
facility: Sanofi-Aventis Investigational Site Number 840011
state: Ohio
city: Middletown
country: United States
facility: Sanofi-Aventis Investigational Site Number 840086
state: Ohio
city: Toledo
country: United States
facility: Sanofi-Aventis Investigational Site Number 840008
state: Ohio
city: Portland
country: United States
facility: Sanofi-Aventis Investigational Site Number 840039
state: Oregon
city: Bethlehem
country: United States
facility: Sanofi-Aventis Investigational Site Number 840118
state: Pennsylvania
city: Philadelphia
country: United States
facility: Sanofi-Aventis Investigational Site Number 840033
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Sanofi-Aventis Investigational Site Number 840012
state: Pennsylvania
city: Pawtucket
country: United States
facility: Sanofi-Aventis Investigational Site Number 840082
state: Rhode Island
city: Woonsocket
country: United States
facility: Sanofi-Aventis Investigational Site Number 840095
state: Rhode Island
city: Charleston
country: United States
facility: Sanofi-Aventis Investigational Site Number 840085
state: South Carolina
city: Spartanburg
country: United States
facility: Sanofi-Aventis Investigational Site Number 840037
state: South Carolina
city: Corpus Christi
country: United States
facility: Sanofi-Aventis Investigational Site Number 840078
state: Texas
city: Temple
country: United States
facility: Sanofi-Aventis Investigational Site Number 840117
state: Texas
city: Seattle
country: United States
facility: Sanofi-Aventis Investigational Site Number 840099
state: Washington
city: Marshfield
country: United States
facility: Sanofi-Aventis Investigational Site Number 840002
state: Wisconsin
city: Bahia Blanca
country: Argentina
facility: Sanofi-Aventis Investigational Site Number 032003
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis Investigational Site Number 032006
city: Ciudad De Buenos Aires
country: Argentina
facility: Sanofi-Aventis Investigational Site Number 032005
city: Salta
country: Argentina
facility: Sanofi-Aventis Investigational Site Number 032007
city: Hornsby
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036004
city: Kingswood
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036001
city: Kurralta Park
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036002
city: Melbourne
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036005
city: Melbourne
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036003
city: Nedlands
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036007
city: Subiaco
country: Australia
facility: Sanofi-Aventis Investigational Site Number 036006
city: Wien
country: Austria
facility: Sanofi-Aventis Investigational Site Number 040001
city: Bonheiden
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056006
city: Bruxelles
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056007
city: Bruxelles
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056002
city: Bruxelles
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056004
city: Gent
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056001
city: Haine-Saint-Paul
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056005
city: Leuven
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056003
city: Porto Alegre
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076004
city: Porto Alegre
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076005
city: Porto Alegre
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076002
city: Rio De Janeiro
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076008
city: Rio De Janeiro
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076003
city: Santo Andre
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076001
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076007
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076006
city: Santiago
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152002
city: Santiago
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152003
city: Santiago
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152001
city: Santiago
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152005
city: Viña Del Mar
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152004
city: Brno
country: Czech Republic
facility: Sanofi-Aventis Investigational Site Number 203002
city: Brno
country: Czech Republic
facility: Sanofi-Aventis Investigational Site Number 203001
city: Praha 5
country: Czech Republic
facility: Sanofi-Aventis Investigational Site Number 203004
city: Odense C
country: Denmark
facility: Sanofi-Aventis Investigational Site Number 208001
city: Ålborg
country: Denmark
facility: Sanofi-Aventis Investigational Site Number 208003
city: Tallinn
country: Estonia
facility: Sanofi-Aventis Investigational Site Number 233002
city: Tartu
country: Estonia
facility: Sanofi-Aventis Investigational Site Number 233001
city: Brest
country: France
facility: Sanofi-Aventis Investigational Site Number 250002
city: Clichy Cx
country: France
facility: Sanofi-Aventis Investigational Site Number 250004
city: La Roche Sur Yon
country: France
facility: Sanofi-Aventis Investigational Site Number 250005
city: Lyon Cedex 03
country: France
facility: Sanofi-Aventis Investigational Site Number 250001
city: Paris
country: France
facility: Sanofi-Aventis Investigational Site Number 250003
city: Aschaffenburg
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276003
city: Essen
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276002
city: Halle / Saale
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276001
city: Magdeburg
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276005
city: Magdeburg
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276004
city: München
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276006
city: Athens
country: Greece
facility: Sanofi-Aventis Investigational Site Number 300005
city: Athens
country: Greece
facility: Sanofi-Aventis Investigational Site Number 300004
city: Heraklion
country: Greece
facility: Sanofi-Aventis Investigational Site Number 300001
city: Ilion, Athens
country: Greece
facility: Sanofi-Aventis Investigational Site Number 300002
city: Patras
country: Greece
facility: Sanofi-Aventis Investigational Site Number 300003
city: Ancona
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380007
city: Aviano
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380005
city: Candiolo
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380004
city: Genova
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380003
city: Milano
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380001
city: Milano
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380002
city: Rozzano
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380008
city: San Giovanni Rotondo
country: Italy
facility: Sanofi-Aventis Investigational Site Number 380006
city: Goyang
country: Korea, Republic of
facility: Sanofi-Aventis Investigational Site Number 410001
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Investigational Site Number 410003
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Investigational Site Number 410005
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Investigational Site Number 410002
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Investigational Site Number 410004
city: Amsterdam
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528004
city: Blaricum
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528001
city: Breda
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528005
city: Rotterdam
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528002
city: Sittard-Geleen
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528003
city: Auckland
country: New Zealand
facility: Sanofi-Aventis Investigational Site Number 554009
city: Christchurch
country: New Zealand
facility: Sanofi-Aventis Investigational Site Number 554010
city: Bergen
country: Norway
facility: Sanofi-Aventis Investigational Site Number 578002
city: Oslo
country: Norway
facility: Sanofi-Aventis Investigational Site Number 578001
city: Stavanger
country: Norway
facility: Sanofi-Aventis Investigational Site Number 578003
city: Czestochowa
country: Poland
facility: Sanofi-Aventis Investigational Site Number 616005
city: Elblag
country: Poland
facility: Sanofi-Aventis Investigational Site Number 616004
city: Krakow
country: Poland
facility: Sanofi-Aventis Investigational Site Number 616007
city: Lodz
country: Poland
facility: Sanofi-Aventis Investigational Site Number 616003
city: Poznan
country: Poland
facility: Sanofi-Aventis Investigational Site Number 616002
city: Rybnik
country: Poland
facility: Sanofi-Aventis Investigational Site Number 616006
city: Wroclaw
country: Poland
facility: Sanofi-Aventis Investigational Site Number 616001
city: San Juan
country: Puerto Rico
facility: Sanofi-Aventis Investigational Site Number 630001
city: Alba Iulia
country: Romania
facility: Sanofi-Aventis Investigational Site Number 642004
city: Bucharest
country: Romania
facility: Sanofi-Aventis Investigational Site Number 642007
city: Bucuresti
country: Romania
facility: Sanofi-Aventis Investigational Site Number 642001
city: Bucuresti
country: Romania
facility: Sanofi-Aventis Investigational Site Number 642002
city: Cluj Napoca
country: Romania
facility: Sanofi-Aventis Investigational Site Number 642003
city: Iasi
country: Romania
facility: Sanofi-Aventis Investigational Site Number 642006
city: Suceava
country: Romania
facility: Sanofi-Aventis Investigational Site Number 642005
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643001
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643006
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643002
city: Saint-Petersburg
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643003
city: St-Petersburg
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643004
city: St-Petersburg
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643007
city: Cape Town
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710004
city: Durban
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710005
city: Durban
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710008
city: Parktown
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710001
city: Port Elizabeth
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710006
city: Pretoria
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710007
city: Pretoria
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710003
city: Barakaldo
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724002
city: Barcelona
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724005
city: Barcelona
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724001
city: Madrid
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724006
city: Madrid
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724003
city: Reus
country: Spain
facility: Sanofi-Aventis Investigational Site Number 724007
city: Stockholm
country: Sweden
facility: Sanofi-Aventis Investigational Site Number 752002
city: Sundsvall
country: Sweden
facility: Sanofi-Aventis Investigational Site Number 752003
city: Uppsala
country: Sweden
facility: Sanofi-Aventis Investigational Site Number 752001
city: Adana
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792005
city: Ankara
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792004
city: Ankara
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792001
city: Izmir
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792002
city: Kayseri
country: Turkey
facility: Sanofi-Aventis Investigational Site Number 792003
city: Dnipropetrovsk
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804005
city: Donetsk
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804004
city: Kharkiv
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804006
city: Kharkov
country: Ukraine
facility: Sanofi-Aventis Investigational Site Number 804002
city: Aberdeen
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826001
city: Bournemouth
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826010
city: Dudley
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826009
city: London
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826008
city: London
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826004
city: London
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826007
city: London
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826011
city: Manchester
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826002
city: Northwood
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826003
city: Sutton
country: United Kingdom
facility: Sanofi-Aventis Investigational Site Number 826005
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.