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Status:

COMPLETED

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

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Collaborating Sponsors:

Dutch Colorectal Cancer Group (DCCG)

Arbeitsgemeinschaft fur Internistische Onkologie

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE3

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...

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 witho...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00085163

    Start Date

    March 1 2004

    Last Update

    October 20 2015

    Active Locations (36)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 9 (36 locations)

    1

    Karl-Franzens-University Graz

    Graz, Austria, A-8010

    2

    Innsbruck Universitaetsklinik

    Innsbruck, Austria, A-6020

    3

    Krankenhaus der Elisabethinen

    Linz, Austria, 4020

    4

    St. Vincent's Hospital

    Linz Donau, Austria, 4010