At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of colon or rectum
- ✓Metastatic disease not amenable to potentially curative treatment
- ✕Prior systemic therapy for metastatic colorectal cancer
- ✕Prior angiogenesis inhibitor treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Multinational, Study Of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
In Brief
A Phase 2 clinical trial evaluating aflibercept, oxaliplatin, and 2 other interventions for Colorectal Neoplasms and Neoplasm Metastasis. Completed, enrolled 268 participants across 37 sites in 7 countries.
Detailed 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.
Study Details
Timeline
Interventions
administration: IV infusion
administration: IV infusion
administration: IV infusion
administration: IV infusion