See leading oncologists explain the science behind their clinical research

The Eastern Cooperative Oncology Group (ECOG) has informational videos available online about their colorectal cancer clinical trials. These videos are intended to help patients and caregivers learn about the trials and where patients can get more information.

If you have any feedback about the videos, please email mike@nyckatz.com.

The trials are:

• E5202: Trial For Patients With Stage II Colon Cancer
• E4203: Trial for Patients With Untreated Metastatic Colorectal Cancer
• E5204 Trial For Patients With Stage II or III Rectal Cancer

E5202: Trial For Patients With Stage II Colon Cancer

You can learn more about this trial by viewing a short informational video featuring Dr. Al Benson, the study chair for this trial:

• Real Media
• Windows Media

Click here for a list of institutions participating in this trial

This randomized phase III study is for patients who have had surgery to remove colon cancer and may benefit from additional treatment. When cancer is found in the colon that extends through the wall of the colon, but not in the lymph nodes or other organs, it is considered Stage II colon cancer.

This 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 and without a new drug, 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 1 and 2, 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 1 and 2, every two weeks for a total of twelve (12) two-week cycles. In addition, they will recieve bevacizumab during one (1) 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.

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:

• E4203 Real Media Video
• E4203 Windows Media Video

Click here for a list of institutions participating in this trial

NEW! Click here for a FAQ about this trial

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.

• Patients in group one will receive a 30-90 minute infusion of bevacizumab, a 2-hour infusion of oxaliplatin, and a 90-minute infusion of irinotecan in weeks 1 and 3

• Patients in groups two and three will receive bevacizumab and oxaliplatin as in group one, a 2-hour infusion of leucovorin, and a 2-day continuous infusion of fluorouracil in weeks 1 and 3

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

E5204 Trial For Patients With Stage II or III Rectal Cancer

• E5204 Real Media Video
• E5204 Windows Media Video

Click here for a list of institutions participating in this trial

This is a Phase II study for individuals who have Stage II or III rectal cancer and have had chemotherapy and radiation prior to having the rectal cancer surgically removed. There have been very few studies of combination chemotherapies for this patient group.

This study will compare the overall survival in patients, and will compare the treatment combination of oxaliplatin, fluorouracil (5-FU) and leucovorin to the same combination of drugs with the addition of bevacizumab. The combination of oxaliplatin, fluorouracil and leucovorin is the standard of care for stage III colon cancer, but this treatment plan has not been evaluated for patients with rectal cancer. We want to see if adding bevacizumab to the other cancer-fighting agents is better for treating rectal cancer patients. We also want to see if adding bevacizumab will help prevent the cancer from coming back. Bevacizumab is the common name for the commercial drug, Avastin.

This is a randomized study, which means that the two chemotherapy treatment combinations are compared with each other to find out if one is better. We expect 2,100 people to take part in this study. You have an equal chance of an assignment to either one. Neither you nor your doctor will have a say as to which group you are assigned, but both you and your doctor will be informed as to which treatment you will receive. You will be assigned to one of the following groups:

• Group A – FOLFOX (acronym commonly used to refer to the following regimen) – this is a two day treatment given every 2 weeks for a total of twelve 2-week cycles. Medications are given before chemotherapy to prevent nausea and vomiting. All of the chemotherapy drugs will be given through a vein. Oxaliplatin is given over 2 hours; leucovorin is given over 2 hours, followed by 5-FU (fluorouracil) given as a quick infusion, followed by 5-FU given as a constant infusion through a portable pump over the next 46 hours.
• Group B – FOLFOX + Bevacizumab

All of the chemotherapy drugs will be given through a vein. Bevacizumab is given over 30-90 minutes, before the oxaliplatin, leucovorin and 5-FU. Oxaliplatin is given over 2 hours; leucovorin is given over 2 hours, followed by 5-FU (5-fluorouracil) given as a quick infusion, followed by 5-FU given as a constant infusion through a portable pump over the next 46 hours.

The treatments are expected to take 6 months. Participants are expected to be followed for 10 years to determine long term effects of the treatment.