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)
Colorectal Neoplasms, Neoplasm Metastasis
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring colorectal cancer, metastatic, anti-angiogenic, irinotecan, 5-FU, FOLFIRI
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.
Sites / Locations
- Sanofi-Aventis Investigational Site Number 840119
- Sanofi-Aventis Investigational Site Number 840074
- Sanofi-Aventis Investigational Site Number 840093
- Sanofi-Aventis Investigational Site Number 840080
- Sanofi-Aventis Investigational Site Number 840076
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- Sanofi-Aventis Investigational Site Number 840006
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- Sanofi-Aventis Investigational Site Number 410001
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- Sanofi-Aventis Investigational Site Number 616001
- Sanofi-Aventis Investigational Site Number 630001
- Sanofi-Aventis Investigational Site Number 642004
- Sanofi-Aventis Investigational Site Number 642007
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- Sanofi-Aventis Investigational Site Number 642006
- Sanofi-Aventis Investigational Site Number 642005
- Sanofi-Aventis Investigational Site Number 643001
- Sanofi-Aventis Investigational Site Number 643006
- Sanofi-Aventis Investigational Site Number 643002
- Sanofi-Aventis Investigational Site Number 643003
- Sanofi-Aventis Investigational Site Number 643004
- Sanofi-Aventis Investigational Site Number 643007
- Sanofi-Aventis Investigational Site Number 710004
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Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo/FOLFIRI
Aflibercept/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
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