Phase 2
N=236
Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
Colorectal Neoplasms · Neoplasm Metastasis
Bottom Line
View on ClinicalTrials.gov: NCT00851084 ↗Enrolled (actual)
236
Serious AEs
37.0%
Results posted
Jun 2013
Primary outcome: Primary: Progression Free Survival (PFS) Rate at 12 Months — 21.2; 25.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- aflibercept (Drug); oxaliplatin (Drug); 5-FU (Drug); Folinic Acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) Rate at 12 Months |
21.2; 25.8 | — |
| SECONDARY Progression Free Survival (PFS) |
8.77; 8.48 | — |
| SECONDARY Overall Objective Response Rate (ORR) |
45.9; 49.1 | — |
| SECONDARY Overall Survival (OS) |
22.31; 19.45 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAE) |
115; 119; 87; 108; 32; 55 | — |
| SECONDARY Immunogenicity of Intravenous (IV) Aflibercept |
105; 1; 7; 2; 45; 1 | — |
Summary
The primary objective of the study is to estimate the progression-free survival rate at 12 months for the two arms of the study.
Secondary objectives include the evaluation of overall objective response rate to treatment, progression-free survival, overall survival, safety and documentation of potential immunogenicity of aflibercept.
This study was a non-comparative randomized trial and was not powered for a comparison of any of the efficacy endpoints.
Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a check on the similarity of the current patients to the historical controls with respect to clinical outcome when given FOLFOX6 treatment.
Eligibility Criteria
Inclusion Criteria
- Histologically proven adenocarcinoma of the colon or the rectum
- Metastatic disease not amenable to potentially curative treatment
Exclusion Criteria
- Prior therapy for metastatic cancer of the colon or the rectum
- Prior treatment with angiogenesis inhibitors
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT00851084). 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.