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

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ClinicalTrials.gov Identifier: NCT00085163
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : October 20, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: celecoxib Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy Phase 3

Detailed Description:



  • 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.


  • 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 Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Multicenter, Double-Blind, Placebo-Controlled Randomized Phase III Study of Adjuvant Therapy With Celecoxib in Combination With Chemotherapy in Patients With Curatively Resected Stage III Colon Cancer
Study Start Date : March 2004
Primary Completion Date : November 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Overall survival as measured by Logrank every 3 months in year 1, every 6 months in years 2-3, and annually thereafter
  2. 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
  3. 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

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the colon

    • 15 cm above anal verge
    • Stage III disease (any pT, N1-2, M0)
  • No rectal cancer
  • Must have undergone curative radical resection (R0 resection) within the past 6 weeks



  • 18 and over

Performance status

  • WHO 0-1

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • AST ≤ 5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN


  • Creatinine ≤ 1.5 times ULN


  • None of the following conditions within the past 6 months:

    • Myocardial infarction
    • Unstable angina
    • Symptomatic congestive heart failure
    • Serious uncontrolled cardiac arrhythmia
    • Cerebrovascular accident or transient ischemic attack
    • Deep vein thrombosis
    • Other significant thromboembolic event


  • No pulmonary embolism within the past 6 months


  • No active gastric or duodenal ulceration within the past year
  • No gastrointestinal bleeding within the past year
  • No partial or complete bowel obstruction
  • No known chronic malabsorption
  • No active inflammatory bowel disease or chronic diarrhea (more than 4 stools/day)


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No AIDS-related illness
  • No prior hypersensitivity to fluorouracil, leucovorin calcium, celecoxib, other COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides
  • No other severe acute or chronic medical condition or laboratory abnormality that would preclude study participation, study drug administration, or study results interpretation
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance
  • No concurrent active infection
  • No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer


Biologic therapy

  • No concurrent sargramostim (GM-CSF) or molgramostim


  • Not specified

Endocrine therapy

  • No more than 4 weeks of concurrent orally/nasally inhaled steroids over a 6-month period

    • Concurrent mometasone (or fluticasone) allowed if patients require ≥ 4 weeks of inhaled steroid therapy
  • At least 30 days since other prior steroids
  • No concurrent hormonal therapy


  • No concurrent radiotherapy


  • See Disease Characteristics
  • No prior total colectomy or other major surgery that would result in substantial alteration in transit to absorption of oral medication


  • More than 30 days since prior investigational medication
  • No prior systemic anticancer treatment for colon cancer
  • No concurrent prophylactic fluconazole
  • No concurrent lithium
  • No concurrent chronic* use of full dose aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or cyclo-oxygenase-2 (COX-2) inhibitors

    • Aspirin at cardioprotective doses (i.e., 80 mg daily or equivalent) allowed
  • No concurrent participation in any other clinical study
  • No other concurrent experimental agents (e.g., other COX-2 inhibitors, matrix metalloproteinase inhibitors, inhibitors of the vascular endothelial growth factor/Flk-1 pathway, or inhibitors of the epidermal growth factor receptor pathway) NOTE: *Chronic use is defined as a frequency of 7 consecutive days (1 week) for more than 3 weeks/year or more than 21 days throughout the year
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085163

Karl-Franzens-University Graz
Graz, Austria, A-8010
Innsbruck Universitaetsklinik
Innsbruck, Austria, A-6020
St. Vincent's Hospital
Linz Donau, Austria, 4010
Krankenhaus der Elisabethinen
Linz, Austria, 4020
Landeskrankenanstalten - Salzburg
Salzburg, Austria, A-5020
Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria, A-1090
Allgemeines Krankenhaus
Wiener Neustadt, Austria, 2700
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerpen, Belgium, B-2020
Hopital Universitaire Erasme
Brussels, Belgium, 1070
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Hopital de Jolimont
Haine Saint Paul, Belgium, 7100
CHU Liege - Domaine Universitaire du Sart Tilman
Liege, Belgium, B-4000
St. Elizabeth Ziekenhuis
Turnhout, Belgium, 2300
Medisch Centrum Haaglanden
's-Gravenhage, Netherlands, 2501 CK
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands, 5211 NL
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 HA
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Gelre Ziekenhuizen - Lokatie Lukas
Apeldoorn, Netherlands, 7334 DZ
Rijnstate Hospital
Arnhem, Netherlands, 6800 TA
Ziekenhuis Lievensberg
Bergen-op-Zoom, Netherlands, 4624 VT
Deventer Ziekenhuisen
Deventer, Netherlands, 7415 CM
Catharina Ziekenhuis
Eindhoven, Netherlands, 5602 ZA
Medisch Spectrum Twente
Enschede, Netherlands, 7500 KA
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Ziekenhuis St Jansdal
Harderwijk, Netherlands, 3840 AC
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
Nijmegen Cancer Center at Radboud University Medical Center
Nijmegen, Netherlands, 6500 HB
Purmerend, Netherlands, 1440 AG
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, Netherlands, 3008 AE
Erasmus MC - Sophia Children's Hospital
Rotterdam, Netherlands, 3015 GJ
Ikazia Ziekenhuis
Rotterdam, Netherlands, NL-3083
Schieland Ziekenhuis
Schiedam, Netherlands, NL-3116
Ziekenhuis de Honte
Terneuzen, Netherlands, NL-4535
Streekziekenhuis Koningin Beatrix
Winterswyk, Netherlands, 7101 BN
Isala Klinieken - locatie Weezenlanden
Zwolle, Netherlands, NL-8000 GM
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Dutch Colorectal Cancer Group (DCCG)
Arbeitsgemeinschaft fur Internistische Onkologie
EFCR - Egyptian foundation for Cancer Research
EORTC GI Group (EORTC 40023)
Federation Francophone de Cancerologie Digestive
GCCD-APIO - Grupo Cooperativo do Cancro Digestivo da Associação Portuguesa de Investigação
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
GOCCI - Gruppo Oncologico Chirurgico Cooperativo Italiano
GOIRC - Gruppo Oncologico Italiano di Ricerca Clinica
SG - Scandinavian Group
TTD - Grupo Español para el Tratamiento de Tumores Digestivos
Study Chair: Cornelis J.H. van de Velde, MD, PhD, FRCS, FRCPS Leiden University Medical Center
Study Chair: Dirk J. Richel, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Chair: Michel Ducreux, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
More Information

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00085163     History of Changes
Other Study ID Numbers: EORTC-40023
First Posted: June 11, 2004    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adenocarcinoma of the colon
stage III colon cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic