OPAL Study: A Study of Avastin (Bevacizumab) in Combination With FOLFOXIRI in Patients With Previously Untreated Metastatic Colorectal Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT00940303
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 5-FU — DRUG
    3200mg/m2 continuous iv infusions, day 1 every 2 weeks
  • bevacizumab [Avastin] — DRUG
    5mg/kg iv infusion, day 1 every 2 weeks
  • irinotecan — DRUG
    165mg/m2 iv infusion, day 1 every 2 weeks
  • leucovorin — DRUG
    200mg/m2 iv infusion, day 1 every 2 weeks
  • oxaliplatin — DRUG
    85mg/m2 iv infusion, day 1 every 2 weeks

Study Details

This single arm study will assess progression-free survival, feasibility of use and safety of Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line treatment in patients with metastatic colorectal cancer. Patients will receive up to 12 bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Key Dates

First listed
Jul 16, 2009
Start date
Jun 30, 2009
Status verified
Nov 2016
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014

Study Design

Enrollment
97 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Progression-free survival [ Time Frame: assessed every 8 weeks up to week 102, 3-monthly during follow-up ]

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