Chemotherapy +/− Bevacizumab for Stage II Colon Cancer

Recruiting at1016 trial locations

Overseen by Al B Benson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies oxaliplatin, leucovorin calcium, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin calcium, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer.

Research Team

Al B Benson

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for patients who've had surgery for stage II colon cancer. They should have stable blood pressure, no severe neuropathy, and no history of inflammatory bowel disease or significant bleeding unrelated to their tumor. Participants must not have started any other treatments for this cancer, be in good physical condition (ECOG 0-2), and agree to use contraception if applicable. Those with certain heart conditions or a history of serious blood clots can't join.

Inclusion Criteria

I have a tumor sample available for specific genetic testing.

Patients must have >= 8 lymph nodes evaluated and reported

Low-risk patients will be registered to Arm C for observation

Exclusion Criteria

I have had a condition where my lymphocytes multiply unusually.

I haven't had any cancer except for skin cancer in the last 5 years.

I have not had a heart attack or unstable angina in the last year.

Treatment Details

Interventions

• Bevacizumab (Monoclonal Antibodies)
• Fluorouracil (Anti-metabolites)
• Laboratory Biomarker Analysis (Other)
• Leucovorin Calcium (Other)
• Oxaliplatin (Alkylating agents)

Trial Overview The study compares two treatment methods after surgery: one group receives chemotherapy drugs oxaliplatin, leucovorin calcium, fluorouracil alone; the other gets these drugs plus bevacizumab, an antibody that may block tumor growth. The goal is to find out which combination is more effective against colon cancer.

Participant Groups

Group I: Arm B (combination chemotherapy, bevacizumab) Experimental Treatment 5 Interventions

Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm C (observation) Active Control 1 Intervention

Patients undergo observation.

Group III: Arm A (oxaliplatin, leucovorin calcium, fluorouracil) Active Control 4 Interventions

Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.

Fluorouracil is already approved in Canada for the following indications:

Approved in Canada as 5-Fluorouracil for:

• Colorectal cancer
• Breast cancer
• Stomach cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School