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

NCT00085163 | Completed Phase 3

• 2 other identifiers: EORTC-40023PETACC-5
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 36

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.

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colon; stage III colon cancer

Outcome Measures

Primary Outcomes (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 Outcomes (3)

• 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

• 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

Interventions

celecoxib DRUG

fluorouracil DRUG

leucovorin calcium DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * AST ≤ 5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * 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 Pulmonary * No pulmonary embolism within the past 6 months Gastrointestinal * 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) Other * 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 PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent sargramostim (GM-CSF) or molgramostim Chemotherapy * 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 Radiotherapy * No concurrent radiotherapy Surgery * See Disease Characteristics * No prior total colectomy or other major surgery that would result in substantial alteration in transit to absorption of oral medication Other * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• Dutch Colorectal Cancer Group (DCCG): collaborator
• Arbeitsgemeinschaft fur Internistische Onkologie: collaborator
• Onkologie: collaborator
• Egyptian Foundation For Cancer Research: collaborator
• EORTC GI Group (EORTC 40023): collaborator
• Federation Francophone de Cancerologie Digestive: collaborator
• GCCD-APIO - Grupo Cooperativo do Cancro Digestivo da Associação Portuguesa de Investigação: collaborator
• Oncológica: collaborator
• Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente: collaborator
• GOCCI - Gruppo Oncologico Chirurgico Cooperativo Italiano: collaborator
• GOIRC - Gruppo Oncologico Italiano di Ricerca Clinica: collaborator
• SG - Scandinavian Group: collaborator
• TTD - Grupo Español para el Tratamiento de Tumores Digestivos: collaborator

Study Sites (36)

Karl-Franzens-University Graz

Graz, A-8010, Austria

Location

Innsbruck Universitaetsklinik

Innsbruck, A-6020, Austria

Location

Krankenhaus der Elisabethinen

Linz, 4020, Austria

Location

St. Vincent's Hospital

Linz Donau, 4010, Austria

Location

Landeskrankenanstalten - Salzburg

Salzburg, A-5020, Austria

Location

Allgemeines Krankenhaus der Stadt Wien

Vienna, A-1090, Austria

Location

Allgemeines Krankenhaus

Wiener Neustadt, 2700, Austria

Location

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, B-2020, Belgium

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Hopital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

CHU Liege - Domaine Universitaire du Sart Tilman

Liège, B-4000, Belgium

Location

St. Elizabeth Ziekenhuis

Turnhout, 2300, Belgium

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5211 NL, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Gelre Ziekenhuizen - Lokatie Lukas

Apeldoorn, 7334 DZ, Netherlands

Location

Rijnstate Hospital

Arnhem, 6800 TA, Netherlands

Location

Ziekenhuis Lievensberg

Bergen op Zoom, 4624 VT, Netherlands

Location

Deventer Ziekenhuisen

Deventer, 7415 CM, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5602 ZA, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Ziekenhuis St Jansdal

Harderwijk, 3840 AC, Netherlands

Location

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Sint Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Nijmegen Cancer Center at Radboud University Medical Center

Nijmegen, 6500 HB, Netherlands

Location

Waterlandziekenhuis

Purmerend, 1440 AG, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

Erasmus MC - Sophia Children's Hospital

Rotterdam, 3015 GJ, Netherlands

Location

Ikazia Ziekenhuis

Rotterdam, NL-3083, Netherlands

Location

Schieland Ziekenhuis

Schiedam, NL-3116, Netherlands

Location

Ziekenhuis de Honte

Terneuzen, NL-4535, Netherlands

Location

Medisch Centrum Haaglanden

The Hague, 2501 CK, Netherlands

Location

Streekziekenhuis Koningin Beatrix

Winterswyk, 7101 BN, Netherlands

Location

Isala Klinieken - locatie Weezenlanden

Zwolle, NL-8000 GM, Netherlands

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Celecoxib; Fluorouracil; Leucovorin; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: March 1, 2004
• Primary Completion: November 1, 2005
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

BE (6); AU (7); NL (23)