To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in combination with cetuximab, biweekly.
This multicenter randomized phase II study will enroll approximately 150 patients with metastatic Colorectal Cancer. Patients are randomized in Arm A(FOLFOX4 in combination with weekly Cetuximab) or Arm B (FOLFOX4 in combination with biweekly Cetuximab). Both efficacy and safety data will be collected. The investigator will assess response to treatment every 8 weeks based on the imaging. Following permanent treatment cessation, patients will be followed-up for survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
151
Arm A FOLFOX4: * Oxaliplatin 85 mg/m² d1 * Leucovorin 200 mg/m² d1+d2, followed by * Bolus 5FU 400 mg/m², followed by * Infusional 5FU 600 mg/m²,over 22 hours, every 2 weeks Cetuximab is administered to arm A of the study as an infusion with initial dose 400 mg/m² in week 1 followed by weekly doses of 250 mg/m². Arm B FOLFOX4: * Oxaliplatin 85 mg/m² d1 * Leucovorin 200 mg/m² d1+d2, followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 600 mg/m², over 22 hours, every 2 weeks Cetuximab is administered to arm B of the study as infusions of 500 mg/m² every two weeks.
LKH Leoben, Abt. für Innere Medizin
Leoben, Styria, Austria
The primary endpoint of the trial is: • Objective response (CR/PR), as assessed by RECIST criteria
Objective response (partial or complete) will be assessed using RECIST criteria. The objective response rate (defined as the rate of subjects with complete response (CR) or partial response (PR)) will be estimated and associated exact two-sided 95% confidence limit (Clopper-Pearson) will be calculated. In addition to the estimates within each treatment group odds ratios and associated 95% CI will be calculated using the Cochran Mantel-Haenszel procedure.
Time frame: The objective response rate - defined as the rate of subjects with complete response (CR) or partial response (PR)
• Progression Free Survival (PFS) • Overall survival • Safety/Adverse events Safety
Secondary objectives are the estimation of differences in PFS and overall survival.
Time frame: he rate of subjects with complete response (CR) or partial response (PR)
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...and 14 more locations