Chemotherapy +/− Celecoxib for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+841 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery. RATIONALE: 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 or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib in treating colon cancer.

Eligibility Criteria

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.

Inclusion Criteria

My cancer has spread to nearby lymph nodes.

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.

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

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 am 18 years old or older.

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

I have no other cancers except for certain allowed types.

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

Exclusion Criteria

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

I am under 18 years old.

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 rectal cancer.

I have moderate to severe lung scarring or inflammation.

Participant Groups

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.

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.

5-fluorouracil is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as 5-FU for: