Study on Chemotherapy With or Without Bevacizumab for Patients Who Had Surgery for Stage II Colon Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT00217737
This clinical trial is exploring whether adding the drug bevacizumab to a standard chemotherapy regimen can improve treatment outcomes for patients who have had surgery for stage II colon cancer. The study compares the effectiveness of chemotherapy alone versus chemotherapy combined with bevacizumab.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to determine if adding bevacizumab, a monoclonal antibody, to the standard chemotherapy drugs oxaliplatin, leucovorin, and fluorouracil (5-FU) can better control stage II colon cancer after surgery. Chemotherapy works by stopping cancer cells from growing and spreading, while bevacizumab may help by interfering with the tumor's ability to grow. The study aims to find out if this combination is more effective than chemotherapy alone.
Description
The study is divided into different treatment groups based on the risk level of the cancer:
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High-Risk Patients (Arms A and B):
- Arm A: Patients receive chemotherapy drugs oxaliplatin, leucovorin, and fluorouracil (5-FU) every two weeks for 12 cycles.
- Arm B: Patients receive the same chemotherapy drugs as in Arm A, plus bevacizumab, every two weeks for 12 cycles. Afterward, they continue with bevacizumab alone for 12 more cycles.
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Low-Risk Patients (Arm C):
- Patients are monitored without additional treatment.
The study will follow patients for several years to monitor their health and any recurrence of cancer. Follow-up visits are scheduled every 3 months for the first 2 years, every 6 months for the next 3 years, and then annually for 10 years.
Eligibility Criteria
Inclusion Criteria
- Must have had surgery for stage II colon cancer.
- The tumor must be located at least 12 cm from the anal verge.
- Must have a tumor sample available for testing to determine risk level.
- No other tumors or history of inflammatory bowel disease.
- Must have a confirmed diagnosis of stage II colon cancer.
- Must have had at least 8 lymph nodes evaluated during surgery.
- Must not have had any prior cancer treatments for this cancer.
- Must be 18 years or older.
- Must have a good performance status (ECOG 0-2).
- Must have adequate blood counts and organ function.
- Must not have any significant bleeding or active ulcers.
- Must not have high blood pressure unless controlled.
- Must not have serious wounds or fractures.
- Must not have significant nerve damage.
- Must not have had major surgery recently.
- Must agree to use contraception if of childbearing potential.
- Must not have a history of certain heart or vascular conditions.
- Must not have a known allergy to platinum-based drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Northeast Alabama Regional Medical Center | 36202 | Anniston | Alabama |
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Clearview Cancer Institute | 35805 | Huntsville | Alabama |
| Mobile Infirmary Medical Center | 36607 | Mobile | Alabama |
| Providence Hospital | 36608 | Mobile | Alabama |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| Mercy Hospital Fort Smith | 72903 | Fort Smith | Arkansas |
| NEA Baptist Memorial Hospital | 72401 | Jonesboro | Arkansas |
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