Open Labeled, Multicenter Phase I/II Study Evaluating the Dose Escalation/Safety of Cetuximab and Oxaliplatin/5-FU/FA/Irinotecan as First-Line Treatment of Metastatic Colorectal Cancer
The first three patients will receive chemotherapy at the dose level 1 for 6 weeks (first
three cycles). The dose will be escalated for the next patients by one dose level if none of
the three patients at a dose level experience a dose-limiting toxicity (DLT) during the
first six weeks. If one of the three patients has a DLT, an additional three patients will
be enrolled at this dose level and the dose will be escalated if no additional patients
experience a DLT. Otherwise, the dose escalation will be stopped, and the last dose will be
regarded as the maximum tolerated dose (MTD). An intra-individual dose escalation is not
The MTD cohort will be expanded to a total of 16 patients.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess a maximal tolerable dose and the safety of a chemotherapy-combination of cetuximab, irinotecan, oxaliplatin and 5-FU/folinic acid as first-line treatment for metastatic colorectal cancer
Gunnar Folprecht, Dr.
University Hospital Dresden, Medical Department I