A Phase 2 interventional study of FOLFOX4 (Oxaliplatin), Cetuximab in Colorectal Cancer, sponsored by Central European Cooperative Oncology Group. Completed at 24 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-18.
Sponsored by Central European Cooperative Oncology Group · Phase 2, Interventional, and Treatment
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 151 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Central European Cooperative Oncology Group is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: FOLFOX4 (Oxaliplatin), Cetuximab
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.
Drug: FOLFOX4 (Oxaliplatin), Cetuximab
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.
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)
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Central European Cooperative Oncology Group