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Anti-metabolites
Chemotherapy +/− Celecoxib for Colorectal Cancer
Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Node positive disease (N1 or N2) as designated in AJCC version 7
Patients with synchronous colon cancers are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 years of follow-up
Awards & highlights
Study Summary
This trial is studying oxaliplatin, leucovorin calcium, and fluorouracil given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.
Who is the study for?
This trial is for adults with stage III colon cancer that's been surgically removed. They must not have had any other cancers (with some exceptions) in the last 5 years, no severe kidney issues, and can't be pregnant or nursing. People with a history of significant gastrointestinal problems, uncontrolled high blood pressure, certain heart conditions, or allergies to platinum drugs and NSAIDs like celecoxib are excluded.Check my eligibility
What is being tested?
The study is testing if adding celecoxib (an anti-inflammatory drug) to a chemotherapy regimen of oxaliplatin, leucovorin calcium, and fluorouracil improves outcomes in patients who've had surgery for stage III colon cancer. Participants will be randomly assigned to receive either the chemo drugs alone or combined with celecoxib.See study design
What are the potential side effects?
Possible side effects include those from chemotherapy such as nausea, fatigue, nerve damage (neuropathy), low blood counts leading to increased infection risk; and from celecoxib like stomach ulcers and bleeding, allergic reactions especially in people sensitive to sulfonamides.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread to nearby lymph nodes.
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I have more than one colon cancer at the same time.
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I do not have severe nerve damage or issues with movement.
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I haven't had stomach or upper intestine ulcers or bleeding in the last 3 years.
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I do not have severe lung scarring or inflammation.
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My colon cancer is confirmed and located above a specific area in my abdomen.
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My tumor was completely removed with clear margins.
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My cancer has not spread to lymph nodes or other parts of my body.
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I agree to stop taking regular NSAIDs or high-dose aspirin.
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I do not have serious heart conditions or uncontrolled high blood pressure.
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I am 18 years old or older.
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My kidney function, measured by creatinine, is within normal limits.
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I have no other cancers except for certain allowed types.
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I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3 years of follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 years of follow-up
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
Overall Survival
Side effects data
From undefined Phase 1 & 2 trial • 21 Patients • NCT0004683936%
Fatigue (lethargy, malaise, asthenia)
27%
Radiation dermatitis
18%
Nausea
9%
Hemoglobin (Hgb)
9%
Cough
9%
Infection without neutropenia
9%
Pleuritic pain
9%
Weight loss
9%
Anorexia
9%
Late RT Toxicity: Lung
9%
Dysphagia-esophageal related to radiation
9%
Vomiting
9%
Edema
9%
Headache
9%
Confusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental: Phase I/II: Celecoxib 400mg BID + RT
Experimental: Phase I: Celecoxib 200mg BID + RT
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm D - FOLFOX and celecoxib (6 treatments)Experimental Treatment4 Interventions
Patients receive FOLFOX every 2 weeks plus celecoxib every day for 6 treatments (12 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive celecoxib alone every day for 3 years total.
Group II: Arm B - FOLFOX and celecoxib (12 treatments)Experimental Treatment4 Interventions
Patients receive FOLFOX every 2 weeks plus celecoxib every day for 12 treatments (24 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive celecoxib alone every day for 3 years total.
Group III: Arm C - FOLFOX and placebo (6 treatments)Active Control4 Interventions
Patients receive FOLFOX every 2 weeks plus placebo every day for 6 treatments (12 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive placebo alone every day for 3 years total.
Group IV: Arm A - FOLFOX and placebo (12 treatments)Active Control4 Interventions
Patients receive FOLFOX every 2 weeks plus placebo every day for 12 treatments (24 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive placebo alone every day for 3 years total.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
leucovorin
2005
Completed Phase 3
~1200
5-fluorouracil
2005
Completed Phase 4
~7960
oxaliplatin
2002
Completed Phase 3
~6370
celecoxib
2003
Completed Phase 3
~3010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,930,626 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
215,111 Total Patients Enrolled
Jeffrey Meyerhardt, MD, MPHStudy ChairDana-Farber Cancer Institute
3 Previous Clinical Trials
335 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have never had an allergic reaction or hypersensitivity to sulfonamides, celecoxib, or NSAIDs (non-steroidal anti-inflammatory drugs).My cancer has spread to nearby lymph nodes.My cancer has spread to nearby lymph nodes but not to distant parts of my body.My cancer is a type of colon cancer, not rectal, confirmed by a surgeon.I have more than one colon cancer at the same time.I do not have severe nerve damage or issues with movement.I haven't had stomach or upper intestine ulcers or bleeding in the last 3 years.I do not have severe lung scarring or inflammation.I have had an ulcer or bleeding in my stomach or upper intestines in the last 3 years.I do not have uncontrolled high blood pressure or severe heart issues.I am under 18 years old.My colon cancer is confirmed and located above a specific area in my abdomen.My tumor was completely removed with clear margins, except possibly the sides.I am 18 years old or older.My kidney function, measured by creatinine, is within normal limits.My tumor was completely removed through surgery.My stage IV cancer was surgically removed.I have cancer in both my colon and rectum at the same time.I regularly use NSAIDs more than twice a week or aspirin over 325 mg at least three times a week.I have colon cancer but not both colon and rectal cancer at the same time.My diagnosis is colon cancer confirmed by tissue analysis.My tumor was completely removed with clear margins.My cancer has not spread to lymph nodes or other parts of my body.I agree to stop taking regular NSAIDs or high-dose aspirin.I do not have serious heart conditions or uncontrolled high blood pressure.I do not have severe nerve damage or problems moving.My cancer has spread to nearby lymph nodes.I have rectal cancer.I have no other cancers except for certain allowed types.I have moderate to severe lung scarring or inflammation.I currently have no signs of cancer in my lymph nodes or elsewhere outside the primary site.I can take care of myself and am up and about more than half of my waking hours.I am taking low-dose aspirin, not more than 100 mg/day.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C - FOLFOX and placebo (6 treatments)
- Group 2: Arm D - FOLFOX and celecoxib (6 treatments)
- Group 3: Arm A - FOLFOX and placebo (12 treatments)
- Group 4: Arm B - FOLFOX and celecoxib (12 treatments)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What indications does celecoxib usually treat?
"Celecoxib is used to treat various conditions, the most common being rheumatoid arthritis in children. It can also be used as part of a therapeutic procedure for advanced esophageal cancers or to treat folate deficiency."
Answered by AI
Could you please expand on the risks associated with celecoxib?
"Given that this is a Phase 3 trial with positive efficacy data as well as several rounds of safety testing, we rate celecoxib as a 3 on our safety scale."
Answered by AI
Are we still looking for applicants for this experiment?
"This particular clinical trial is no longer searching for patients as of March 18th, 2022. The trial was initially posted on June 1st, 2010. If you are looking for other active trials, 815 are actively searching for patients with colorectal carcinoma and 607 are searching for patients to test celecoxib."
Answered by AI
What other investigations have there been surrounding celecoxib?
"As of now, there are 600+ clinical trials worldwide that are researching celecoxib. Most of these trials are in their third phase of testing, with 200 of them having completed or nearing the completion of their clinical trial. Guangzhou, Guangdong has the most trials for celecoxib, with 26427 locations running trials for the medication."
Answered by AI
How many test subjects are contained within this clinical trial?
"This particular study is not enrolling new patients at the moment. It was first announced on June 1st, 2010 and was most recently updated on March 18th, 2022. For individuals searching for active clinical trials, 815 trials are currently recruiting for colorectal carcinoma and 607 trials are recruiting for celecoxib."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
Arizona
New York
Other
How old are they?
18 - 65
What site did they apply to?
Hardin Memorial Hospital
Albert Einstein College of Medicine
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I’m only on flouricil.
PatientReceived 2+ prior treatments
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