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

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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)

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

Trial contacts and locations

37

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Data sourced from clinicaltrials.gov

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