Celecoxib Combined With Fluorouracil and Leucovorin in Treating Patients With Resected Stage III Adenocarcinoma (Cancer) of the Colon

Phase 3

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00085163
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether fluorouracil and leucovorin are more effective with or without celecoxib in treating resected stage III adenocarcinoma (cancer) of the colon.

PURPOSE: This randomized phase III trial is studying celecoxib, fluorouracil, and leucovorin to see how well they work compared to fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer.

Detailed Description

OBJECTIVES:

Primary

* Compare disease-free survival of patients with curatively resected stage III adenocarcinoma of the colon treated with adjuvant fluorouracil and leucovorin calcium with or without celecoxib.

Secondary

* Compare the overall survival, the occurrence of new primary colon cancer, and the development of new polyps in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to ≥ 4 tumor-positive lymph nodes (yes vs no), form of adjuvant chemotherapy (infusional vs bolus), low-dose aspirin for cardiovascular prophylaxis (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive fluorouracil and leucovorin calcium IV for up to 6 courses in the absence of disease recurrence or unacceptable toxicity. Patients also receive oral celecoxib twice daily.

* Arm II: Patients receive oral placebo twice daily and fluorouracil and leucovorin calcium as in arm I.

In both arms, treatment with celecoxib or placebo continues for 3 years in the absence of disease recurrence or unacceptable toxicity.

Patients are followed annually for 2 years.

PROJECTED ACCRUAL: A total of 1,450 patients (725 per treatment arm) will be accrued for this study within 2 years.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2004-06-10
• Study First Submitted QC: 2004-06-10
• Study First Posted: 2004-06-11
• Primary Completion: 2005-11
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival as measured by Logrank every 3 months in year 1, every 6 months in years 2-3, and annually thereafter

Secondary Outcome Measures

Name	Time	Method
Toxicity as measured by CTC AE version 2.0 every 3 months in year 1, every 6 months in years 2-3, and annually thereafter
Overall survival as measured by Logrank every 3 months in year 1, every 6 months in years 2-3, and annually thereafter
Time occurrence of new primary colon cancer and new polyps as measured by Logrank every 3 months in year 1, every 6 months in years 2-3, and annually thereafter

Trial Locations

Locations (36)

Karl-Franzens-University Graz; 🇦🇹 Graz, Austria

Innsbruck Universitaetsklinik; 🇦🇹 Innsbruck, Austria

St. Vincent's Hospital; 🇦🇹 Linz Donau, Austria

Krankenhaus der Elisabethinen; 🇦🇹 Linz, Austria

Landeskrankenanstalten - Salzburg; 🇦🇹 Salzburg, Austria

Allgemeines Krankenhaus der Stadt Wien; 🇦🇹 Vienna, Austria

Allgemeines Krankenhaus; 🇦🇹 Wiener Neustadt, Austria

Ziekenhuis Netwerk Antwerpen Middelheim; 🇧🇪 Antwerpen, Belgium

Hopital Universitaire Erasme; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

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