A Phase II Study of Irinotecan and Panitumumab as 3rd Line Treatment of Patients With Metastatic Colorectal Cancer Without KRAS Mutations
Colorectal cancer is one of the most frequent types of cancer in Denmark with approximately
3,400 diagnosed patients per year. The prognosis for these patients is still very poor and
more than half of them will develop metastatic disease and thus be candidates for
In Denmark 5-FU and Oxaliplatin or Irinotecan has been used for several years either as
combination or mono therapy. In recent years biological antibodies targeted against EGFR
have been added to this treatment. A newly developed antibody is Panitumumab, which enables
treatment every 3 weeks instead of weekly administration.
The effect of EGFR activation is mediated through intracellular pathways involving the KRAS
protein. It has been proven that a mutation of KRAS causes the KRAS protein to be constantly
activated, and patients with these mutations do not benefit from antibodies against EGFR.
Approximately 40% of the patients present these mutations.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Every 9 weeks. Up to 6 months
Anders Jakobsen, Professor
Denmark: National Board of Health