Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer

Sponsor
Central European Cooperative Oncology Group
Study ID
NCT00286130
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan — DRUG
  • FOLFOX 6 — DRUG
    FOLFOX 6: * Oxaliplatin 100 mg/m² d1 concurrent with * Leucovorin 400 mg/m², followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:
  • FOLFIRI — DRUG
    FOLFIRI: * Irinotecan 180 mg/m² day 1 concurrent with * Leucovorin 400 mg/m² followed by * Bolus 5FU 400 mg/m², followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks

Study Details

In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety. The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first

Key Dates

Start date
Jul 31, 2005
Status verified
Apr 2012
Completion
Oct 31, 2007

Study Design

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

Arms

  • Active Comparator: FOLFOX 6
    FOLFOX 6: * Oxaliplatin 100 mg/m² d1 concurrent with * Leucovorin 400 mg/m², followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:
  • Active Comparator: FOLFIRI
    FOLFIRI: * Irinotecan 180 mg/m² day 1 concurrent with * Leucovorin 400 mg/m² followed by * Bolus 5FU 400 mg/m², followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks

Primary Outcome Measure

the percentage of patients surviving without disease progression in each arm at 9 months

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