← Back to Search

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

Must not have

Uncontrolled high blood pressure, unstable angina, history of myocardial infarction or cerebrovascular accident, New York Heart Association class III or IV heart failure

Age below 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 years of follow-up

Awards & highlights

Pivotal Trial

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.

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.

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 below

Select...

My cancer has spread to nearby lymph nodes.

Select...

I have more than one colon cancer at the same time.

Select...

I do not have severe nerve damage or issues with movement.

Select...

I haven't had stomach or upper intestine ulcers or bleeding in the last 3 years.

Select...

I do not have severe lung scarring or inflammation.

Select...

My colon cancer is confirmed and located above a specific area in my abdomen.

Select...

My tumor was completely removed with clear margins.

Select...

My cancer has not spread to lymph nodes or other parts of my body.

Select...

I agree to stop taking regular NSAIDs or high-dose aspirin.

Select...

I do not have serious heart conditions or uncontrolled high blood pressure.

Select...

I am 18 years old or older.

Select...

My kidney function, measured by creatinine, is within normal limits.

Select...

I have no other cancers except for certain allowed types.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have uncontrolled high blood pressure or severe heart issues.

Select...

I am under 18 years old.

Select...

My stage IV cancer was surgically removed.

Select...

I have cancer in both my colon and rectum at the same time.

Select...

I regularly use NSAIDs more than twice a week or aspirin over 325 mg at least three times a week.

Select...

I have rectal cancer.

Select...

I have moderate to severe lung scarring or inflammation.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 years of follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease-free Survival

Secondary study objectives

Overall Survival

Side effects data

From undefined Phase 1 & 2 trial • 21 Patients • NCT00046839

36%

Fatigue (lethargy, malaise, asthenia)

27%

Radiation dermatitis

18%

Nausea

Hemoglobin (Hgb)

Cough

Pleuritic pain

Infection without neutropenia

Weight loss

Anorexia

Late RT Toxicity: Lung

Dysphagia-esophageal related to radiation

Vomiting

Edema

Headache

Confusion

100%

80%

60%

40%

20%

Study treatment Arm

Experimental: Phase I/II: Celecoxib 400mg BID + RT

Experimental: Phase I: Celecoxib 200mg BID + RT

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

5-fluorouracil

2005

Completed Phase 4

~8440

oxaliplatin

2002

Completed Phase 3

~6370