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Name of the Trial

Phase III Randomized Study of Irinotecan Hydrochloride-Based Chemotherapy and Cetuximab With Versus Without Bevacizumab in Patients With Metastatic Colorectal Cancer That Progressed on First-Line Therapy (SWOG-S0600). See the protocol summary ³.

Principal Investigators

Dr. Philip Gold Principal Investigator

Dr. Philip Gold and Dr. Anthony Shields, Southwest Oncology Group; Dr. Axel Grothey, North Central Cancer Treatment Group; Dr. Leonard Saltz, Cancer and Leukemia Group B; Dr. Steven Cohen, Eastern Cooperative Oncology Group; and Dr. Scott Berry, NCIC-Clinical Trials Group.

Why This Trial Is Important

Patients with metastatic colorectal cancer are often treated with the drug oxaliplatin and the monoclonal antibody bevacizumab in combination with other drugs. If the cancer progresses while the patient is being treated with these agents, second-line therapy with different drugs may be initiated.

Bevacizumab inhibits the formation of new blood vessels that tumors need for continued growth and has been shown to help extend the survival of patients with advanced or metastatic colorectal cancer when used as part of initial, or first-line, therapy. It is unknown, however, whether continuing bevacizumab treatment will help improve survival when used in second-line therapy in patients whose cancer has progressed despite first-line treatment with bevacizumab and chemotherapy.

In this trial, patients with metastatic colorectal cancer that has progressed on first-line therapy containing oxaliplatin and bevacizumab will be treated with the agents irinotecan and cetuximab. The patients will also be randomly assigned to receive either a low dose of bevacizumab, a high dose of bevacizumab, or no additional bevacizumab.

"The goal of this trial is to determine whether there is benefit in continuing to treat patients with bevacizumab if they have progressed on a regimen containing it," said Dr. Gold.

"Bevacizumab may make tumors more susceptible to chemotherapy by normalizing the tumor vasculature, and emerging data suggest that bevacizumab and cetuximab may produce a synergistic effect," Dr. Gold added. "So, there is a good rationale to see if continuing bevacizumab in combination with cetuximab will help improve outcomes for patients, perhaps helping them live longer."

For More Information

See the lists of entry criteria and trial contact information ³ at or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.

Glossary Terms

A drug used to treat several types of cancer, including certain types of colorectal, lung, breast, and kidney cancers and glioblastoma. It is also being studied in the treatment of other types of cancer. Bevacizumab binds to vascular endothelial growth factor (VEGF) and may prevent the growth of new blood vessels that tumors need to grow. It is a type of antiangiogenesis agent and a type of monoclonal antibody. Also called Avastin.

A monoclonal antibody used to treat certain types of head and neck cancer, and colorectal cancer that has spread to other parts of the body. It is also being studied in the treatment of other types of cancer. Monoclonal antibodies are made in the laboratory and can locate and bind to cancer cells. Cetuximab binds to the epidermal growth factor receptor (EGFR), which is found on the surface of some types of cancer cells. Also called Erbitux.

The active ingredient in a drug used alone or in combination with other drugs to treat colon cancer or rectal cancer that has spread to other parts of the body or has come back after treatment with fluorouracil. It is also being studied in the treatment of other types of cancer. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill cancer cells. It is a type of topoisomerase inhibitor and a type of camptothecin analog.

Having to do with metastasis, which is the spread of cancer from the primary site (place where it started) to other places in the body.

A drug used together with other drugs to treat colorectal cancer that is advanced or has come back. It is also being studied in the treatment of other types of cancer. Oxaliplatin attaches to DNA in cells and may kill cancer cells. It is a type of platinum compound. Also called Eloxatin.

Treatment that is given when initial treatment (first-line therapy) doesn’t work, or stops working.