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Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery

NCT01150045 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2527

Last updated 2026-05-19

Study results available
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Summary

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.

Conditions

Interventions

DRUG

celecoxib

Patients receive celecoxib 400 mg administered by mouth, once daily.

DRUG

5-fluorouracil

Patients receive 400 mg/m\^2 intravenous bolus then 2400 mg/m\^2 continuous intravenous infusion over 46-48 hours.

OTHER

placebo

Patients receive placebo administered by mouth, once daily.

DRUG

oxaliplatin

Patients receive 85 mg/m\^2 intravenous over two hours.

DRUG

leucovorin

Patients receive 400 mg/m\^2 intravenous over two hours.

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Meyerhardt, MD, MPH · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2020-02-28
Completion
2022-08-11

Countries

  • United States
  • Canada
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01150045 on ClinicalTrials.gov