Bi-weekly Cetuximab Combined With FOLFOX-6 as First-line Treatment in Metastatic Colorectal Cancer Patients With Wild-type K-ras Status
For years the effective treatment of advanced CRC was limited to 5-FU. Combination of 5-FU
or a 5-FU analog with oxaliplatin, which has some antitumor activity as a single agent,
shows synergistic activity. Combining oxaliplatin with a twice monthly folinic acid/5-FU
schedule leads to a further improvement in first-line treatment of advanced CRC thus
emerging to a standard regimen in first-line therapy of mCRC.
Cetuximab is normally given as a weekly schedule. As recently shown a biweekly schedule with
500 mg/m² instead of the weekly standard regimen (initial dose of 400 mg/m² followed by 250
mg/m² every week) exhibits similar pharmacokinetic results with a comparable efficacy.
In order to improve the convenience for the patients, this study will evaluate the efficacy
and safety of a bi-weekly combination of cetuximab with FOLFOX. Out of the various FOLFOX
regimens the most convenient FOLFOX-6 schedule is chosen for the study, which has been
tested before in two studies in combination with the standard weekly schedule of cetuximab.
Recent data suggest a decreased efficacy of cetuximab in patients bearing a k-ras mutation
in their CRC. Therefore only patients with no evidence for a mutated k-ras gene in the
colorectal carcinoma cells will be included in this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (RECIST-Criteria)
Every 8 weeks
Tanja Trarbach, MD
University of Duisburg-Essen Medical School