IRB Number:

5-04

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

This research study is being done in patients who have had surgery for colon cancer to: Find out the effectiveness of the following six different combinations of drugs in stopping the return of your colon cancer these treatments, namely cetuximab (C225), irinotecan (CPT-11) and oxaliplatin (OXAL), are considered investigational in the stage of colon cancer that you have. These drugs are given in combination with standard chemotherapy drugs called 5-fluorouracil (5-FU) and leucovorin (CF).

Who is Eligible to Participate in the Study?

Men or women over the age of 18 who have had surgery for colon cancer may be eligible to participate in this research study.

What is Involved With this Study?

You will be put into one of the six study groups by chance (like pulling a number out of a hat). This is called randomization. A computer will decide which group you will be in.

• Group A will be treated with OXAL, 5-FU, and CF for 24 weeks.


• Group B will be treated with CPT-11, 5-FU, and CF for 24 weeks.


• Group C will be treated with OXAL, 5-FU, and CF for 12 weeks then CPT-11, 5-FU, and CF for 12 weeks.


• Groups (D, E, F) are these same three treatments with C225 added to them.


• Group D: Group A + C225


• Group E: Group B + C225


• Group F: Group C + C225

Treatment with these medications will require the placement of an IV tube into a vein under the skin of your chest wall.

You will also be asked to fill out some questionnaires before you begin treatment, at cycle six of treatment, and again at the end of treatment. The questionnaires will ask questions about how you are feeling, your lifestyle habits, medicine use, diet and daily activities, family history and also how you felt about taking part in this study. The questionnaires should take about 60 minutes to fill out.

How long will the Study run?

You will be in the study for the rest of your life.

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL

Last updated: 05/20/2009