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Name of the Trial

Phase III Randomized Study of Irinotecan (CPT-11) and/or Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer (NCCTG-N0147). See the protocol summary ³.

Principal Investigators

Dr. Steven Alberts Principal Investigator

Dr. Steven Alberts and Dr. Frank Sinicrope, North Central Cancer Treatment Group.

Why This Trial Is Important

Colon cancer is among the most common cancer types in the United States. Surgery is often used to treat colon cancer, but even with potentially curative surgery, some cancer cells can remain in the body, especially if cancer has spread to the surrounding lymph nodes (stage III colon cancer). To fight these cancer cells, doctors may treat patients with post-operative (adjuvant) chemotherapy. Biological agents, such as monoclonal antibodies, may also be added to the chemotherapy.

This trial will include six different treatment groups. Patients will be randomly assigned to receive one of three different combinations of chemotherapy with or without the monoclonal antibody cetuximab. Cetuximab targets a protein, epidermal growth factor receptor, that may help some types of cancer cells to grow.

"For patients with lymph node involvement, the recurrence rate after surgery is historically about 50 to 70 percent," said Dr. Alberts. "Traditional adjuvant chemotherapy with fluorouracil and leucovorin, however, has produced definite improvements. Our hope is that the more active agents now available to us will further reduce the risk of recurrence without producing a lot of additional side effects compared with current standard therapy.

"By comparing these different regimens, we hope to determine what will become the state-of-the-art in adjuvant therapy for colon cancer," added Dr. Alberts.

Notes:

• As of June 1, 2005, this trial has been changed to a comparison of two treatment groups. Each group will receive FOLFOX chemotherapy (a combination of oxaliplatin, 5-fluorouracil, and leucovorin); one of the groups will also be treated with cetuximab.
• As of October 24, 2008, this trial has been temporarily closed to the enrollment of patients aged 70 years or older.

For More Information

See the lists of entry criteria and trial contact information ³ 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.

Glossary Terms

A type of protein made in the laboratory that can locate and bind to substances in the body, including tumor cells. There are many kinds of monoclonal antibodies. Each monoclonal antibody is made to find one substance. Monoclonal antibodies are being used to treat some types of cancer and are being studied in the treatment of other types. They can be used alone or to carry drugs, toxins, or radioactive materials directly to a tumor.