Trial intelligence / Profile preview

A-ICOX Regimen (Bevacizumab, Capecitabine, Oxaliplatin) in Advanced Colorectal Cancer

NCT00177307Phase 2

Key facts

Status
Completed
Start
Jan 2005
Primary completion
Feb 2012
Countries
1
Sponsor
University of Pittsburgh
Modality
Monoclonal Antibodies
Conditions
colorectal cancer (CRC)
01

Overview

Phase 2, open-label, single-arm trial of bevacizumab in colorectal cancer (CRC), sponsored by University of Pittsburgh. Primary endpoint: Progression Free Survival at 27 months. Started Jan 2005; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Oxaliplatin, Capecitabine, and Bevacizumab

    Bevacizumab 5 mg/kg q2w, Capecitabine 2500 mg/m2/d (d1-8 q2w), Oxaliplatin 85 mg/m2 (d1 q2w)

03

Who it enrols

Patients with untreated advanced colorectal cancer, measurable disease, ECOG 0-2, and adequate organ function. Excludes patients eligible for surgery, prior metastatic therapy, or prior oxaliplatin/bevacizumab.

04

Endpoints

Primary

  • Progression Free Survival

Secondary

  • Response Rate

  • Overall Survival

  • 1-, 2-, and 3-year Overall Survival

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