OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum.

Sponsor
Hoffmann-La Roche
Study ID
NCT00577031
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab [Avastin] — DRUG
    7.5mg iv on day 1 of each 3 week cycle
  • Oxaliplatin — DRUG
    130mg/m2 iv on day 1 of each 3 week cycle
  • Xeloda — DRUG
    1000mg/m2 po bid on days 1-14 of each 3 week cycle

Study Details

This single arm study will evaluate the efficacy and safety of a first-line regimen of Avastin and XELOX (oxaliplatin + Xeloda) in patients with metastatic cancer of the colon or rectum. Patients will receive 21-day cycles of treatment, comprising Avastin 7.5mg/kg iv on day 1, oxaliplatin 130mg/m2 iv on day 1, and Xeloda 1000mg/m2 po twice daily on days 1-14, for a maximum of 6 months. Patients with stable disease or complete or partial response may continue on Avastin therapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Key Dates

First listed
Dec 19, 2007
Start date
Feb 29, 2008
Status verified
Jul 2015
Primary completion
Aug 31, 2011
Completion
Aug 31, 2011

Study Design

Enrollment
205 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Progression-Free Survival (PFS): Percentage of Participants With Progressive Disease or Death [ Time Frame: Baseline and Day 1 of every cycle until disease progression or death up to 5 years ]

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