Name of the Trial
Phase II Randomized Study of Bevacizumab and Cetuximab With or Without Irinotecan in Patients With Irinotecan-Refractory Metastatic Colorectal Cancer (MSKCC-03135). See the protocol summary at http://cancer.gov/clinicaltrials/MSKCC-03135.

Principal Investigator
Dr. Leonard Saltz of Memorial Sloan-Kettering Cancer Center

Why Is This Trial Important?
Colorectal cancer (cancer that occurs in the colon or the rectum) is among the most commonly diagnosed and most deadly cancers in the United States. Colorectal cancer can usually be cured if detected early; however, if it has spread (metastasized) to other parts of the body, it is often fatal. Scientists are eager to find more effective treatments or combinations of treatments for metastatic colorectal cancer.

Monoclonal antibodies, such as cetuximab (Erbitux) and bevacizumab (Avastin), are playing an increasingly important role in cancer therapy. Cetuximab targets a protein that some types of cancer need for growth. Bevacizumab interferes with the ability of a tumor to establish a blood supply. Combining cetuximab and bevacizumab with traditional chemotherapy drugs, such as irinotecan, may slow the progression of disease or even improve survival for patients with metastatic colorectal cancer.

"With this trial, we're taking the two newest targeted therapies for colorectal cancer and combining them to see if they are more effective than standard chemotherapy, either as a stand-alone treatment or in combination with irinotecan," said Dr. Saltz.

Who Can Join This Trial?
Researchers seek to enroll 150 patients aged 18 and over with metastatic colorectal cancer that has previously been treated with irinotecan. Additionally, patients must be well enough to carry out most normal, daily activities and must not be largely confined to bed or chair, and patients must be willing and able to be treated weekly at one of the participating centers conducting this trial. See the full list of eligibility criteria for this trial at http://cancer.gov/clinicaltrials/MSKCC-03135.

Where Is This Trial Taking Place?
Multiple study sites in the United States are recruiting patients for this trial. See the list of study sites at http://cancer.gov/clinicaltrials/MSKCC-03135.

Who to Contact
See the list of study contacts at http://cancer.gov/clinicaltrials/MSKCC-03135 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.