E4203 Trial for Patients With Untreated Metastatic Colorectal Cancer

You can learn more about this trial by viewing a short informational video featuring Dr. Neal J. Meropol, one of the study chairs for this trial:

Note to institutions: Use of these videos for patient education requires approval of your institution's IRB.

This is a Phase II study for people who have colon or rectal cancer that has spread to other organs or has come back. The participants must be at least 18 years old, have measurable disease, and have had surgery or a biopsy more than 4 weeks earlier.

The purpose of the study is to test whether measuring the amount of a specific protein in the tumor (thymidylate syntahse) can help select better therapy for patients with colon and rectal cancer. Standard therapies for colorectal cancer use the drug fluorouracil (5-FU), which kills cancer cells by blocking the action of the TS protein, along with other drugs. Research studies suggest that if the level of TS protein in the tumor is high, then 5-FU is less likely to kill the cancer cells and/or shrink the tumor. So far, no study has tested whether choosing a therapy that does not contain 5-FU will be more effective in patients whose tumors have high levels of the TS protein.

In this study one group of patients who have a high level of TS protein in the tumor will receive treatment that does not include 5-FU; instead these patients will receive bevacizumab with oxaliplatin and irinotecan. The combination of bevacizumab/oxaliplatin/irinotecan is considered experimental in this study.

In order to be part of this study, a biopsy of the tumor that has spread to other organs or has come back locally must be done. If the patient has already had such a biopsy, and there is tissue left over, this can be used to allow measurement of TS protein. If not, the patient will be asked to have a biopsy done so that the TS protein can be measured in the tumor. The tissue will be sent to a central laboratory and the amount of TS protein in the tumor tissue will then be measured. If the amount of TS protein is low, then the patient will be assigned to receive what is considered an acceptable therapy for advanced colorectal cancer (a combination of oxaliplatin, 5-FU, leucovorin and bevacizumab). If the amount of TS protein is high, then the patient will be randomized into one of two study groups. One study group will have the same treatment mentioned above and the other arm will use oxaliplatin, bevacizumab with irinotecan (another drug that has shown benefit in patients with colorectal cancer). The patients whose tumors have high TS levels will have an equal chance of being placed in either study group.

Treatment may be repeated every 4 weeks for as long as benefit is shown and patients will be evaluated periodically for 4 years.

You can find additional information about colorectal cancer and its treatment at the following web sites:


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Eastern Cooperative Oncology Group:

E4203 Trial for Patients With Untreated Metastatic Colorectal Cancer