Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
This randomized phase III study is for patients who have had surgery to remove colon cancer and may benefit from additional treatment.
When colon cancer extends through the wall of the colon, but not in the lymph nodes or other organs, it is considered Stage II colon cancer.
The study is designed to:
- Determine whether specific biological features (often called tumor markers) seen in tests done on a tumor can be used to predict recurrence of tumors in patients with Stage II colon cancer.
- Compare the effects of a combination of chemotherapy drugs, given with or without a biologic agent, Avastin® (bevacizumab) on patients with Stage II colon cancer at high-risk for recurrence. The US Food and Drug Administration (FDA) considers the use of bevacizumab to be investigational for treating Stage II colon cancer.
There must be a biopsy of the tumor to evaluate two specific tumor markers. Samples of tumor tissue will be forwarded to a designated laboratory and examined to determine whether the participant will be assigned to the high-risk or low-risk group.
If the marker evaluation of the tumor shows that the patient is at low risk for tumor recurrence, the patient will have no further treatment for the cancer, including chemotherapy.
If the marker evaluation shows that the patient is at high-risk for tumor recurrence, then the participant will be randomized into one of two study groups. There will be an equal chance of being in either one of the two groups and neither the patient nor the doctor can choose the group.
- One group will receive a standard two-day regimen of chemotherapy, often referred to as FOLFOX (fluorouracil/leucovorin/oxaliplatin), given on days one and two, every two weeks for a total of twelve (12) two-week cycles.
- Those randomized to the second group will also receive a standard two-day chemotherapy, referred to as FOLFOX (fluorouracil/leucovorin/oxaliplatin), given on days one and two, every two weeks for a total of twelve (12) two-week cycles. In addition, they will receive bevacizumab during one day of each cycle. After completing the twelve cycles of chemotherapy, patients will continue to receive bevacizumab alone for twelve (12) subsequent treatments, given once every two weeks.
Participants will be required to have a temporary tube place into a vein in the chest or arm during the course of treatment to receive the 5-FU (fluorouracil) for a 46-hour period during each cycle.
Participants will be followed for up to 10 years to determine the long-term effects of the study treatments and the effectiveness of the tumor marker tests.
More information about the trial, including sites where it is being conducted is available from the National Cancer Institute.