Phase 3
N=1,226
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
Colorectal Neoplasms · Neoplasm Metastasis
Bottom Line
View on ClinicalTrials.gov: NCT00561470 ↗Enrolled (actual)
1,226
Serious AEs
40.5%
Results posted
Sep 2012
Primary outcome: Primary: Overall Survival (OS) — 12.06; 13.50 months — p=0.0032
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) (Drug); FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
12.06; 13.50 | 0.0032 sig |
| SECONDARY Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC) |
4.67; 6.90 | 0.00007 sig |
| SECONDARY 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 |
11.1; 19.8 | 0.0001 sig |
| SECONDARY Number of Participants With Adverse Events (AE) |
592; 606; 198; 294; 29; 37 | — |
| SECONDARY 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 |
18; 8; 2; 1 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00561470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.