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

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.

Conditions

• Colorectal Cancer

Interventions

DRUG

celecoxib

DRUG

fluorouracil

DRUG

leucovorin calcium

PROCEDURE

adjuvant therapy

Sponsors & Collaborators

• Dutch Colorectal Cancer Group (DCCG)

  collaborator UNKNOWN

• Arbeitsgemeinschaft fur Internistische Onkologie

  collaborator OTHER

• Onkologie

  collaborator UNKNOWN

• Egyptian Foundation For Cancer Research

  collaborator OTHER

• EORTC GI Group (EORTC 40023)

  collaborator UNKNOWN

• Federation Francophone de Cancerologie Digestive

  collaborator OTHER

• GCCD-APIO - Grupo Cooperativo do Cancro Digestivo da Associação Portuguesa de Investigação

  collaborator UNKNOWN

• Oncológica

  collaborator UNKNOWN

• Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

  collaborator OTHER

• GOCCI - Gruppo Oncologico Chirurgico Cooperativo Italiano

  collaborator UNKNOWN

• GOIRC - Gruppo Oncologico Italiano di Ricerca Clinica

  collaborator UNKNOWN

• SG - Scandinavian Group

  collaborator UNKNOWN

• TTD - Grupo Español para el Tratamiento de Tumores Digestivos

  collaborator UNKNOWN

• European Organisation for Research and Treatment of Cancer - EORTC

  lead NETWORK

Principal Investigators

• Cornelis J.H. van de Velde, MD, PhD, FRCS, FRCPS · Leiden University Medical Center

• Dirk J. Richel, MD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

• Michel Ducreux, MD, PhD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-03-31

Primary Completion

2005-11-30

Countries

• Austria
• Belgium
• Netherlands

Study Locations