OPTIMOX-aflibercept as First-line Therapy in Patients With Unresectable Metastatic Colorectal Cancer

NCT01802684 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2017-03-01

No results posted yet for this study

Summary

Evaluation of feasibility of adding aflibercept to an oxaliplatin-based regimen rather than a continuous administration of chemotherapy until progression, in order to decrease the risk of severe toxicities.

Conditions

  • Unresectable Metastatic Colorectal Cancer

Interventions

BIOLOGICAL

aflibercept

Aflibercept (VEGF Trap) Recombinant human protein, at 25 mg/ml Dose : 4 mg/Kg -Day 1, q2w Route of administration: Intravenous (60 min infusion)

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY
  • GERCOR - Multidisciplinary Oncology Cooperative Group

    lead OTHER

Principal Investigators

  • Benoist Chibaudel, MD · Hôpital Saint Antoine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-11-30
Completion
2016-06-30

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01802684 on ClinicalTrials.gov