Trial intelligence / Profile preview

OLIVIA: Bevacizumab with mFOLFOX-6 or FOLFOXIRI in Colorectal Cancer

NCT00778102Phase 2

Key facts

Status
Completed
Start
Oct 2008
Primary completion
Oct 2013
Countries
4
Sponsor
Roche
Modality
Monoclonal Antibodies
Conditions
colorectal cancer (CRC)
01

Overview

Phase 2, randomised, open-label trial of bevacizumab in colorectal cancer (CRC) (2 arms), sponsored by Roche. Primary endpoint: Percentage of Participants With Complete Resection or Residual (Microscopic or Macroscopic) Tumor up to 5 years. Started Oct 2008; status: completed.

02

Design

2 arms
Study design
RandomizedOpen-label
  • mFOLFOX-6 + Bevacizumab

    5-FU, Leucovorin, Oxaliplatin, Bevacizumab

  • FOLFOXIRI + Bevacizumab

    5-FU, Leucovorin, Oxaliplatin, Irinotecan, Bevacizumab

03

Who it enrols

Adult patients with unresectable liver metastasis secondary to colorectal cancer, ECOG 0-1, and no prior systemic treatment for metastatic disease.

04

Endpoints

Primary

  • Percentage of Participants With Complete Resection or Residual (Microscopic or Macroscopic) Tumor

Secondary

  • Time to Resection

  • Percentage of Participants With Histopathological Response

  • Percentage of Participants With Complete or Major Histopathological Response

  • Percentage of Participants Experiencing Relapse Following Curative Resection

  • Relapse-Free Survival

  • Progression-Free Survival

  • Overall Survival

  • Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0

05

Results

Not all primary endpoints met

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