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.
Disclosure: C3 accepts unrestricted educational grants and charitable donations from Bristol-Myers Squibb along with other pharmaceutical and biotech companies. Our corporate sponsor and policy page can be found on this page.
June 10, 2008 at 5:06 pm, Eugene Manning said:
Please send me a FAX number so I can send you CT reports. I would like to know if I am a candidate for more surgery. I currently am receiving Camptisar, Avastin, 5FU & Leukinvorin weekly (1 day) for 3 weeks and then skip a week. I have peaked after 18 treatments. CEA is down from 65 to 12.7
June 10, 2008 at 9:48 pm, Kate Murphy said:
C3 cannot provide specific medical advice, nor could we comment on your CT-scans so sending them to us wouldn’t help you.
We do encourage you to talk over the possibility of surgery with your own doctor or with a surgeon at a large cancer center.
It is important that any discussion of chemotherapy and surgery be a multidisciplinary team one with the surgeon and medical oncologist working closely together to determine if tumors can be operated on and removed and when the best time to do that is.
Ask your doctor to explain your CT-scans and whether there is any possibility of surgery.
If you’d like more help, you can call our Answer Line at 1-877-4CRC-111 (1-877-427-2111)
Thanks for commenting,
Kate Murphy
Director of Research Communication
C3: Colorectal Cancer Coalition.