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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 is This Trial 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.

Who Can Join This Trial?

Researchers want to enroll 4,800 patients aged 18 and over, diagnosed with stage III colon cancer, who have had their tumors surgically removed. See the complete list of eligibility criteria ⁴.

Where Is This Trial Taking Place?

Multiple study sites in the United States are enrolling patients for this trial. See the full list of study sites ⁵.

Who to Contact

See the list of study contacts ⁵ 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 laboratory-produced substance that can locate and bind to cancer cells wherever they are in the body. Many monoclonal antibodies are used in cancer detection or therapy; each one recognizes a different protein on certain cancer cells. Monoclonal antibodies can be used alone, or they can be used to deliver drugs, toxins, or radioactive material directly to a tumor.