Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC

Sponsor
Hellenic Oncology Research Group
Study ID
NCT00469443
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 72 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Irinotecan 150mg/m2 IV on day 1 every 2 weeks for 10 cycles
  • 5-Fluorouracil — DRUG
    5-Fluorouracil 400 mg/m2 infused over 10 min IV and 5-FU 600 mg/m2 infused over 22 hours IV, on Day 1 and 2 (De Grammont regimen), every 2 weeks for 10 cycles
  • Leucovorin — DRUG
    Leucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles
  • Capecitabine — DRUG
    Capecitabine 2000mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
  • Bevacizumab — DRUG
    Bevacizumab 5mg/kg IV on day 1 every 2 weeks for 10 cycles
  • Bevacizumab — DRUG
    Bevacizumab 7,5mg/kg IV on day 1 every 3 weeks for 6 cycles
  • Irinotecan — DRUG
    Irinotecan 250mg/m2 IV on day 1 every 3 weeks for 6 cycles

Study Details

This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with the addition of Avastin as 1st line treatment of colorectal cancer.

Key Dates

Start date
Dec 31, 2006
Status verified
Aug 2010
Primary completion
Feb 28, 2010
Completion
Feb 28, 2010

Study Design

Enrollment
330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    FOLFIRI/Avastin
  • Experimental: 2
    XELIRI/Avastin

Primary Outcome Measure

Time To Progression [ Time Frame: 1 year ]

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