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Stage III Cetuximab Trial Closed

It doesn’t help patients to add Erbitux to FOLFOX chemotherapy after surgery for stage III colon cancer a data monitoring committee for a clinical trial testing the new treatment has decided.

Because the analysis showed that patients were not benefiting from adding Erbitux to FOLFOX chemotherapy, the trial has been closed according to a news release from the National Cancer Institute.

The study — N0147 — randomized patients with stage III colon cancer after surgery to receive either FOLFOX chemotherapy alone or FOLFOX and Erbitux.  Once information about the importance of the KRAS gene for Erbitux benefit was discovered, all patients in the trial had their tumors tested for KRAS mutations and only those with normal or wild-type KRAS were included in the DMC analysis.

According to the NCI news report , there was some initial evidence that addition of Erbitux may have been harmful, especially in patients older than 70.

The study was led by the North Center Cancer Treatment Group (NCCTG) and sponsored by the NCI.

NCCTG N)-147 was officially titled: A Randomized Phase III Trial of Oxaliplatin Plus 5-Fluorouracil/Leucovorin With or Without Cetuximab After Curative Resection for Patients with Stage III Colon Cancer

Currently the use of Erbitux for colorectal cancer is limited to patients with metastatic disease who do not have mutations in the KRAS gene.

Disclosure: C3 has accepted funding for projects and educational programs from ImClone Systems and Eli Lilly in the form of unrestricted educational grants. C3 has ultimate authority over website content.

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