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)

This study has been completed.
Sponsor:
Collaborators:
Regeneron Pharmaceuticals
NSABP Foundation Inc
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00561470
First received: November 20, 2007
Last updated: September 27, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Colorectal Neoplasms
Neoplasm Metastasis
Drug: Placebo
Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Drug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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.


  • 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) ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: Yes ]

    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.


  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 1226
Study Start Date: November 2007
Study Completion Date: June 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
4 mg/kg of Aflibercept was administered IV over 1 hour on Day 1, every 2 weeks.
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561470

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Locations
United States, Alabama
Sanofi-Aventis Investigational Site Number 840119
Birmingham, Alabama, United States, 35203
Sanofi-Aventis Investigational Site Number 840074
Muscle Shoals, Alabama, United States, 35661
United States, Arizona
Sanofi-Aventis Investigational Site Number 840093
Hot Springs, Arizona, United States, 71913
United States, California
Sanofi-Aventis Investigational Site Number 840080
Anaheim, California, United States, 92801
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Fountain Valley, California, United States, 92708
Sanofi-Aventis Investigational Site Number 840120
Fountain Valley, California, United States, 92708
Sanofi-Aventis Investigational Site Number 840073
Greenbrae, California, United States, 94904-2007
Sanofi-Aventis Investigational Site Number 840101
Hayward, California, United States, 94545
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La Jolla, California, United States, 92037
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Loma Linda, California, United States, 92354
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Chile
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Santiago, Chile, 7650635
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Santiago, Chile, 7510032
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Santiago, Chile, 8380455
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Santiago, Chile, 8380456
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Viña Del Mar, Chile, 2540364
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Brno, Czech Republic, 65653
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Brno, Czech Republic, 62500
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Praha 5, Czech Republic, 15006
Denmark
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Odense C, Denmark, 5000
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Ålborg, Denmark, 9100
Estonia
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Tartu, Estonia, 50406
France
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Brest, France, 29200
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Clichy Cx, France, 92118
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La Roche Sur Yon, France, 85925
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Paris, France, 75013
Germany
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Aschaffenburg, Germany, 63739
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München, Germany, 81737
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Athens, Greece, 11527
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Athens, Greece, 11522
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Patras, Greece, 26500
Italy
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Ancona, Italy, 60032
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Aviano, Italy, 33081
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Candiolo, Italy, 10060
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Genova, Italy, 16128
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Milano, Italy, 20133
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Rozzano, Italy, 20089
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Goyang, Korea, Republic of, 410-760
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Seoul, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 120-752
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Seoul, Korea, Republic of, 138-736
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Russian Federation
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Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 129128
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St-Petersburg, Russian Federation, 191104
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Pretoria, South Africa, 0001
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Sanofi-Aventis Investigational Site Number 724001
Barcelona, Spain, 08035
Sanofi-Aventis Investigational Site Number 724006
Madrid, Spain, 28035
Sanofi-Aventis Investigational Site Number 724003
Madrid, Spain, 28041
Sanofi-Aventis Investigational Site Number 724007
Reus, Spain, 43201
Sweden
Sanofi-Aventis Investigational Site Number 752002
Stockholm, Sweden, 171 76
Sanofi-Aventis Investigational Site Number 752003
Sundsvall, Sweden, 851 86
Sanofi-Aventis Investigational Site Number 752001
Uppsala, Sweden, 751 85
Turkey
Sanofi-Aventis Investigational Site Number 792005
Adana, Turkey, 01120
Sanofi-Aventis Investigational Site Number 792001
Ankara, Turkey, 06500
Sanofi-Aventis Investigational Site Number 792004
Ankara, Turkey, 06100
Sanofi-Aventis Investigational Site Number 792002
Izmir, Turkey, 35340
Sanofi-Aventis Investigational Site Number 792003
Kayseri, Turkey, 38039
Ukraine
Sanofi-Aventis Investigational Site Number 804005
Dnipropetrovsk, Ukraine
Sanofi-Aventis Investigational Site Number 804004
Donetsk, Ukraine, 83092
Sanofi-Aventis Investigational Site Number 804006
Kharkiv, Ukraine, 61037
Sanofi-Aventis Investigational Site Number 804002
Kharkov, Ukraine, 61070
United Kingdom
Sanofi-Aventis Investigational Site Number 826001
Aberdeen, United Kingdom, AB25 2ZD
Sanofi-Aventis Investigational Site Number 826010
Bournemouth, United Kingdom, BH7 7DW
Sanofi-Aventis Investigational Site Number 826009
Dudley, United Kingdom, DY1 2HQ
Sanofi-Aventis Investigational Site Number 826004
London, United Kingdom, N18 1QX
Sanofi-Aventis Investigational Site Number 826011
London, United Kingdom, SW3 6JJ
Sanofi-Aventis Investigational Site Number 826007
London, United Kingdom, SE1 7EH
Sanofi-Aventis Investigational Site Number 826008
London, United Kingdom, EC1A 7BE
Sanofi-Aventis Investigational Site Number 826002
Manchester, United Kingdom, M20 4BX
Sanofi-Aventis Investigational Site Number 826003
Northwood, United Kingdom, HA6 2RN
Sanofi-Aventis Investigational Site Number 826005
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
NSABP Foundation Inc
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00561470     History of Changes
Other Study ID Numbers: EFC10262, EudraCT 2007-000820-42
Study First Received: November 20, 2007
Results First Received: August 17, 2012
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration
Spain: Spanish Agency of Medicines
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Sanofi:
colorectal cancer
metastatic
anti-angiogenic
irinotecan
5-FU
FOLFIRI

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Oxaliplatin
Irinotecan
Camptothecin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 18, 2014