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

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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