Erbitux® (cetuximab) has met the primary endpoint of the stage III CRYSTAL clinical trial for patients with metastatic colon or rectal cancer– to increase the time before cancer begins to progress again (progression-free survival) . Over 1000 patients whose colorectal cancer had spread to other parts of their bodies took part in the trial. None had received previous chemotherapy for metastatic colorectal cancer.
Patients in the internationally-based trial were randomly assigned to receive either FOLFIRI chemotherapy alone or FOLFIRI plus Erbitux®. FOLFIRI combines irinotecan (Camptosar®) with leucovorin and a continuous infusion of fluorouracil (5FU).
Study results were announced on January 10, 2007 in news releases from ImClone Systems and Bristol-Myers Squibb, manufacturers of Erbitux®, and Merck KGaA, ImClone’s European partner, who conducted the clinical trial. CRYSTAL clinical trial results have been submitted for presentation at the 2007 American Society for Clinical Oncology meeting in Chicago where more detailed information will be available.
WHAT THIS MEANS FOR PATIENTS
Positive results from the CRYSTAL trial may offer another first-line treatment option for patients with metastatic colon or rectal cancer.
However, full results of the trial, including the differences in how long before cancer began to progress and the treatment’s side effects, have not yet been reported. More information will be available in the coming months and will be discussed at medical meetings.
Until more details are known, first-line treatment with Erbitux and FOLFIRI remains experimental and is not yet available in community settings outside of clinical trials.
Erbitux® (cetuximab) is a monoclonal antibody that targets the epidermal growth factor receptors (EGFR) on cancer cells, blocking colorectal cancer development. It is currently approved by the FDA to treat metastatic colorectal cancer that has already progressed on other first-line chemotherapy treatments. As second-line therapy it may be given alone or in combination with FOLFIRI.
An additional first-line treatment trial for metastatic colorectal cancer (CALGB-C80405) is currently underway and recruiting patients to determine whether combining front-line chemotherapy with Avastin® (bevacizumab), Erbitux®, or both Avastin and Erbitux will improve overall survival.
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