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

This study has been completed.
Sponsor:
Collaborators:
Dutch Colorectal Cancer Group (DCCG)
AIO, CAO - Arbeitsgemeinschaft Internistische Onkologie, Chirurgische Arbeitsgemeinschaft für
Onkologie
EFCR - Egyptian foundation for Cancer Research
EORTC GI Group (EORTC 40023)
FFCD - Fédération Francophone de Cancérologie Digestive
GCCD-APIO - Grupo Cooperativo do Cancro Digestivo da Associação Portuguesa de Investigação
Oncológica
GISCAD - Gruppo Italiano Studio Carcinomi 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
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00085163
First received: June 10, 2004
Last updated: October 28, 2013
Last verified: October 2013

June 10, 2004
October 28, 2013
March 2004
November 2005   (final data collection date for primary outcome measure)
Disease-free survival as measured by Logrank every 3 months in year 1, every 6 months in years 2-3, and annually thereafter [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00085163 on ClinicalTrials.gov Archive Site
  • Overall survival as measured by Logrank every 3 months in year 1, every 6 months in years 2-3, and annually thereafter [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: Yes ]
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Celecoxib Combined With Fluorouracil and Leucovorin in Treating Patients With Resected Stage III Adenocarcinoma (Cancer) of the Colon
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: celecoxib
  • Drug: fluorouracil
  • Drug: leucovorin calcium
  • Procedure: adjuvant therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
November 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Netherlands
 
NCT00085163
EORTC-40023, EORTC-40023, PETACC-5
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
  • Dutch Colorectal Cancer Group (DCCG)
  • AIO, CAO - Arbeitsgemeinschaft Internistische Onkologie, Chirurgische Arbeitsgemeinschaft für
  • Onkologie
  • EFCR - Egyptian foundation for Cancer Research
  • EORTC GI Group (EORTC 40023)
  • FFCD - Fédération Francophone de Cancérologie Digestive
  • GCCD-APIO - Grupo Cooperativo do Cancro Digestivo da Associação Portuguesa de Investigação
  • Oncológica
  • GISCAD - Gruppo Italiano Studio Carcinomi 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
European Organisation for Research and Treatment of Cancer - EORTC
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP