Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
Last Modified: 4/30/2009  First Published: 9/16/2005
Alternate Title Basic Trial Information Trial Description Purpose Eligibility Treatment/Intervention Trial Contact Information Related Information Registry Information
Alternate Title
Phase III Randomized Study of Oxaliplatin, Leucovorin Calcium, and Fluorouracil With Versus Without Bevacizumab in Patients With Resected Stage II Colon Cancer and at High Risk for Recurrence Based on Molecular Markers
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase III | Treatment | Temporarily closed | 18 and over | ECOG-E5202 E5202, NCT00217737 |
Special Category:
CTSU trial, NCI - CMS pilot project trial, NCI Web site featured trial Trial Description Purpose: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab after surgery may kill any remaining tumor cells or prevent the cancer from coming back. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone or observation only in treating colon cancer.
This randomized phase III trial is studying oxaliplatin, leucovorin, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin, and fluorouracil or observation only in treating patients who have undergone surgery for stage II colon cancer. Eligibility: Eligibility criteria include the following: Final eligibility for a clinical trial is determined by the health professionals conducting the trial. Treatment/Intervention: Some patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups. Other patients will be assigned to group three. Patients in group one will receive a 2-hour infusion of oxaliplatin and a 2-hour infusion of leucovorin once in week 1. They will also receive a 2-day continuous infusion of fluorouracil in week 1. Treatment may repeat every 2 weeks for up to 12 courses. Patients in group two will receive a 2-hour infusion of oxaliplatin and a 2-hour infusion of leucovorin once in week 1. They will also receive a 2-day continuous infusion of fluorouracil and a 30- to 90-minute infusion of bevacizumab once in week 1. Treatment may repeat every 2 weeks for up to 12 courses. Patients will then receive bevacizumab alone for up to 12 additional courses. Patients in group three will undergo observation only. Patients will be evaluated every 3 months for 1-2 years, every 6 months for 3 years, and once a year for up to 10 years from study entry.
Important: For more details about this trial, refer to the Health Professional version 6 of the trial summary. If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on
NCI's Web site 7.
Trial Contact Information
Trial Lead Organizations Eastern Cooperative Oncology Group | | | Al Benson, MD, FACP, Protocol chair | | | | Peter O'Dwyer, MD, BCh, Protocol co-chair | | | |
Related Information Featured trial article 8
Registry Information | | Official Title | | A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers | | Trial Start Date | | 2005-08-04 | | Trial Completion Date | | 2011-04-17 (estimated) | | Registered in ClinicalTrials.gov | | NCT00217737 9 | | Date Submitted to PDQ | | 2005-08-02 | | Information Last Verified | | 2009-04-30 | | NCI Grant/Contract Number | | CA21115 |
Glossary Terms
bevacizumab (beh-vuh-SIH-zoo-mab)
A monoclonal antibody used in the treatment of colorectal cancer that has spread. It is also being studied in the treatment of other types of cancer. Bevacizumab binds to vascular endothelial growth factor (VEGF) and may prevent the growth of new blood vessels that tumors need to grow. It is a type of antiangiogenesis agent. Also called Avastin.
blood
A tissue with red blood cells, white blood cells, platelets, and other substances suspended in fluid called plasma. Blood takes oxygen and nutrients to the tissues, and carries away wastes.
cell (sel)
The individual unit that makes up the tissues of the body. All living things are made up of one or more cells.
chemotherapy (KEE-moh-THAYR-uh-pee)
Treatment with drugs that kill cancer cells.
colon cancer (KOH-lun KAN-ser)
Cancer that forms in the tissues of the colon (the longest part of the large intestine). Most colon cancers are adenocarcinomas (cancers that begin in cells that make and release mucus and other fluids).
combination chemotherapy (KOM-bih-NAY-shun KEE-moh-THAYR-uh-pee)
Treatment using more than one anticancer drug.
continuous infusion (kon-TIN-yoo-us in-FYOO-zhun)
The administration of a fluid into a blood vessel, usually over a prolonged period of time.
drug
Any substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic.
eligibility criteria (EH-lih-jih-BIH-lih-tee kry-TEER-ee-uh)
In clinical trials, requirements that must be met for an individual to be included in a study. These requirements help make sure that patients in a trial are similar to each other in terms of specific factors such as age, type and stage of cancer, general health, and previous treatment. When all participants meet the same eligibility criteria, it gives researchers greater confidence that results of the study are caused by the intervention being tested and not by other factors.
fluorouracil (floor-oh-YOOR-uh-sil)
A drug used to treat symptoms of cancer of the colon, breast, stomach, and pancreas. It is also used in a cream to treat certain skin conditions. Fluorouracil stops cells from making DNA and it may kill cancer cells. It is a type of antimetabolite. Also called 5-fluorouracil and 5-FU.
infusion (in-FYOO-zhun)
A method of putting fluids, including drugs, into the bloodstream. Also called intravenous infusion.
leucovorin (LOO-koh-VOR-in)
The active ingredient in a drug used to lessen the toxic effects of substances that block the action of folic acid, especially the anticancer drug methotrexate. Leucovorin is used to treat some types of anemia and is also used together with fluorouracil to treat colorectal cancer. It is also being studied in the treatment of other types of cancer and other conditions. Leucovorin is a form of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Also called folinic acid.
monoclonal antibody (MAH-noh-KLOH-nul AN-tee-BAH-dee)
A type of protein made in the laboratory that can locate and bind to substances in the body, including tumor cells. There are many kinds of monoclonal antibodies. Each monoclonal antibody is made to find one substance. Monoclonal antibodies are being used to treat some types of cancer and are being studied in the treatment of other types. They can be used alone or to carry drugs, toxins, or radioactive materials directly to a tumor.
observation (OB-ser-VAY-shun)
Closely monitoring a patient's condition but withholding treatment until symptoms appear or change. Also called active surveillance, expectant management, and watchful waiting.
open biopsy
A procedure in which a surgical incision (cut) is made through the skin to expose and remove tissues. The biopsy tissue is examined under a microscope by a pathologist. An open biopsy may be done in the doctor’s office or in the hospital, and may use local anesthesia or general anesthesia. A lumpectomy to remove a breast tumor is a type of open biopsy.
oxaliplatin (ok-SAL-ih-pla-tin)
A drug used together with other drugs to treat colorectal cancer that is advanced or has come back. It is also being studied in the treatment of other types of cancer. Oxaliplatin attaches to DNA in cells and may kill cancer cells. It is a type of platinum compound. Also called Eloxatin.
phase III trial
A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.
progression (proh-GREH-shun)
In medicine, the course of a disease, such as cancer, as it becomes worse or spreads in the body.
radiation therapy (RAY-dee-AY-shun THAYR-uh-pee)
The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiotherapy.
randomized clinical trial
A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.
stage II colorectal cancer (...KOH-loh-REK-tul KAN-ser)
Cancer has spread outside the colon and/or rectum to nearby tissue, but it has not gone into the lymph nodes. Also called Dukes B colorectal cancer.
surgery (SER-juh-ree)
A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.
systemic therapy (sis-TEH-mik THAYR-uh-pee)
Treatment using substances that travel through the bloodstream, reaching and affecting cells all over the body.
tumor (TOO-mer)
An abnormal mass of tissue that results when cells divide more than they should or do not die when they should. Tumors may be benign (not cancer), or malignant (cancer). Also called neoplasm.
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Table of Links
1 | http://www.cancer.gov/clinicaltrials/learning |
2 | http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials |
3 | http://www.cancer.gov/clinicaltrials/learning/questions-to-ask-about-participat ing |
4 | http://www.nlm.nih.gov/medlineplus/druginformation.html |
5 | http://www.cancer.gov/clinicaltrials/ECOG-E5202#EntryCriteria_CDR0000443410 |
6 | http://www.cancer.gov/clinicaltrials/ECOG-E5202 |
7 | http://cancer.gov/clinicaltrials |
8 | http://www.cancer.gov/clinicaltrials/ft-ECOG-E5202 |
9 | http://clinicaltrials.gov/ct/show/NCT00217737 |
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