Clinical trial NCT00085163 (phase 3, status: completed)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: celecoxib, fluorouracil, leucovorin calcium
SMILES: COC1=CC=C(C=C1)C(=O)CC(=O)C1=CC=C(C=C1)C(C)(C)C, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1
Eligibility criteria:

        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