Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer (AFFIRM)

Sanofi

Status and phase: Completed; Phase 2

Conditions: Neoplasm Metastasis; Colorectal Neoplasms

Treatments: Drug: Folinic Acid; Drug: aflibercept; Drug: 5-FU; Drug: oxaliplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00851084

EFC10668

EudraCT 2008-004178-41

Details and patient eligibility

About

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.

Enrollment: 268 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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268 participants in 2 patient groups

mFOLFOX6 only

Active Comparator group

Description:

modified FOLFOX6 chemotherapy regimen

Treatment:

Drug: 5-FU

Drug: oxaliplatin

Drug: Folinic Acid

mFOLFOX6 + aflibercept

Experimental group

Description:

modified FOLFOX6 chemotherapy regimen in combination with aflibercept

Treatment:

Drug: 5-FU

Drug: oxaliplatin

Drug: aflibercept

Drug: Folinic Acid