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Anti-metabolites

Chemotherapy +/− Bevacizumab for Stage II Colon Cancer

Phase 3
Waitlist Available
Led By Al B Benson
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The distal extent of the tumor must be >= 12 cm from the anal verge on endoscopy or as determined by surgical examination
Patients must have paraffin-embedded tumor specimen available for evaluation of microsatellite instability and loss of heterozygosity at 18q, to determine high risk versus low risk
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Study Summary

This trial is testing a combination of drugs to treat patients who have had surgery for stage II colon cancer, to see if it is more effective than a standard combination of drugs.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Chemotherapy may cause nausea, fatigue, nerve damage (neuropathy), low blood counts leading to increased infection risk or bleeding problems. Bevacizumab might add risks like high blood pressure, bleeding issues, slow wound healing and could affect organs like kidneys.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is located at least 12 cm from the anal opening, as confirmed by a doctor.
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I have a tumor sample available for specific genetic testing.
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I will ensure my tissue samples are sent for analysis immediately and no later than 50 days after surgery.
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I do not have more than one tumor at the same time.
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I do not have a tumor in my appendix.
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I do not have a history of inflammatory bowel disease.
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I have hereditary non-polyposis colorectal cancer.
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I have never had cancer spread to distant parts of my abdomen.
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My colon cancer is confirmed as Stage II adenocarcinoma.
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My surgery removed all visible cancer without leaving any behind.
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I have not had a complete blockage or tear in my intestines.
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I haven't started any treatment for my cancer.
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I do not have any other cancer besides the one being treated.
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I am able to care for myself and perform daily activities.
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My liver is functioning well, or I have a condition like Gilbert's that affects my bilirubin levels.
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My liver tests are normal or near normal.
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My liver tests, specifically AST, are within normal limits.
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My kidney function is normal, with creatinine levels not exceeding 1.5 times the upper limit.
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My kidney function is good, with a urine protein level under control.
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I have not had significant bleeding unrelated to my colon cancer in the last 6 months.
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My blood pressure is under 150/90 mmHg and I am on a stable blood pressure medication plan.
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I do not have any serious wounds, skin ulcers, or unhealed bone fractures.
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I do not have severe numbness, tingling, or muscle weakness.
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I have not had any surgery or invasive procedures recently.
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I agree to use effective birth control during and for 3 months after the study, and I am not pregnant or breastfeeding.
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I do not have any serious health conditions that would stop me from taking the study drugs.
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I have not had a stroke or mini-stroke recently.
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I have not had heart issues, stroke, or severe mental/addiction problems recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-free survival
Secondary outcome measures
Impact of tumor biologic characteristics and their relationship to overall survival
Incidence of adverse events graded by NCI CTCAE 4.0
Overall survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (combination chemotherapy, bevacizumab)Experimental Treatment5 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 Control1 Intervention
Patients undergo observation.
Group III: Arm A (oxaliplatin, leucovorin calcium, fluorouracil)Active Control4 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Leucovorin Calcium
2011
Completed Phase 3
~12290
Fluorouracil
2014
Completed Phase 3
~11540
Oxaliplatin
2011
Completed Phase 4
~2560

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,565 Previous Clinical Trials
41,220,190 Total Patients Enrolled
Al B BensonPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
235 Total Patients Enrolled

Media Library

Fluorouracil (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT00217737 — Phase 3
Colon Cancer Research Study Groups: Arm C (observation), Arm A (oxaliplatin, leucovorin calcium, fluorouracil), Arm B (combination chemotherapy, bevacizumab)
Colon Cancer Clinical Trial 2023: Fluorouracil Highlights & Side Effects. Trial Name: NCT00217737 — Phase 3
Fluorouracil (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00217737 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please tell me how many different medical facilities are participating in this clinical trial?

"100 patients are being recruited from medical centres such as Cottonwood Hospital Medical Center in Murray, Hutchinson Regional Medical Center in Hutchinson, and Meeker County Memorial Hospital in Litchfield, as well as 100 other locations."

Answered by AI

For what purpose is Fluorouracil most commonly prescribed?

"Fluorouracil is an effective treatment for various medical conditions including, but not limited to, joints, rectal carcinoma, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

How does Fluorouracil's efficacy compare to other cancer treatments?

"At this time, 884 live studies are investigating Fluorouracil with 272 of those in the third stage of clinical trials. Many of the Guangzhou, Guangdong trials are based in Guangzhou, but there are a total of 39664 locations running studies for Fluorouracil."

Answered by AI

Are there serious side effects associated with Fluorouracil?

"There is some evidence to support Fluorouracil's efficacy, as it is a Phase 3 trial. Additionally, there is safety data from multiple rounds of testing, warranting a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Duke Raleigh Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~16 spots leftby Mar 2024