A Study of Avastin (Bevacizumab) in Combination With mFOLFOX-6 or FOLFOXIRI in Patients With Metastatic Colorectal Cancer.

Sponsor
Hoffmann-La Roche
Study ID
NCT00778102
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • 5-FU — DRUG
    Bolus 400mg/m2, day 1 every 2 weeks
  • 5-FU — DRUG
    3200mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks
  • 5-FU — DRUG
    2400mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks
  • Irinotecan — DRUG
    165mg/m2 1-hour iv infusion, day 1 every 2 weeks
  • Leucovorin — DRUG
    400mg/m2 2-hour iv infusion, day 1 every 2 weeks
  • Leucovorin — DRUG
    200mg/m2 2-hour iv infusion, day 1 every 2 weeks
  • Oxaliplatin — DRUG
    85mg/m2 2-hour iv infusion, day 1 every 2 weeks
  • bevacizumab [Avastin] — DRUG
    5mg/kg iv day 1 every 2 weeks

Study Details

This 2 arm study will compare the resection rate of liver metastases and safety of surgery in patients with metastatic colorectal cancer and primarily unresectable liver metastases receiving treatment with Avastin in combination with 5-FU, leucovorin and oxaliplatin with irinotecan (FOLFOXIRI) or without irinotecan (mFOLFOX-6) as first line treatment. Patients will be randomized to receive Avastin (5mg/kg iv every 2 weeks) in combination with each of these two standard neoadjuvant chemotherapy regimens. The anticipated time on study treatment is until surgery, disease progression, unacceptable toxicity or patient refusal, and the target sample size is \<100 individuals.

Key Dates

Start date
Oct 31, 2008
Status verified
Nov 2016
Primary completion
Oct 31, 2013
Completion
Oct 31, 2013

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Active Comparator: 2

Primary Outcome Measure

Percentage of Participants With Complete Resection or Residual (Microscopic or Macroscopic) Tumor [ Time Frame: Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery) ]

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