Trial intelligence / Profile preview

FOLFIRI Plus Bevacizumab as First-Line Treatment for Metastatic Colorectal Cancer

NCT00354978Phase 2

Key facts

Status: Completed
Start: Jan 2005
Primary completion: Mar 2011
Countries: 1
Sponsor: University of Texas MD Anderson Cancer Center
Modality: Monoclonal Antibodies

Drugs: bevacizumab
Conditions: colorectal cancer (CRC)

Overview

Phase 2, open-label, single-arm trial of bevacizumab in colorectal cancer (CRC), sponsored by University of Texas MD Anderson Cancer Center. Primary endpoint: Progression-Free Survival up to 75 months. Started Jan 2005; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

FOLFIRI plus Bevacizumab
Bevacizumab alone for the first dose, then Bevacizumab + FOLFIRI every 14 days.

Who it enrols

Adult patients with metastatic colorectal adenocarcinoma, no prior chemotherapy for metastatic disease, ECOG PS 0-2, adequate organ function, and well-controlled blood pressure.

Endpoints

Primary

Progression-Free Survivalup to 75 months

Secondary

Objective Response Rateup to 75 months
Duration of Objective Responseup to 75 months
Overall Survivalup to 75 months
Dynamic Contrast-Enhanced Magnetic Resonance Imagingup to 75 months
Plasma Proteomicsup to 75 months
Safety and Tolerabilityup to 75 months

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