Clinical trial NCT00064181 (phase 3, status: completed)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: folfiri regimen, capecitabine, celecoxib, fluorouracil, irinotecan hydrochloride, leucovorin calcium
SMILES: FC1=CNC(=O)NC1=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, 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, CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12, 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 or rectum

          -  Metastatic disease

          -  Measurable disease

               -  Patients who received prior radiotherapy must have measurable or evaluable
                  disease outside the radiotherapy field

          -  No CNS metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  WHO 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  WBC at least 3,000/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Bilirubin no greater than 2 times upper limit of normal (ULN)

          -  AST and ALT no greater than 2.5 times ULN (5 times ULN in the presence of liver
             metastases)

        Renal

          -  Creatinine clearance at least 51 mL/min

          -  No severe renal impairment

        Cardiovascular

          -  No severe cardiac disease

          -  No uncontrolled angina pectoris

          -  No myocardial infarction within the past 6 months

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for 6 months after study
             participation

          -  No active Crohn's disease

          -  No other malignancy except adequately treated carcinoma in situ of the cervix or
             nonmelanoma skin cancer

          -  No other uncontrolled severe medical condition

          -  No psychological, familial, sociological, or geographical condition that would
             preclude study compliance and follow-up

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent active or passive immunotherapy for colon cancer

        Chemotherapy

          -  No prior chemotherapy for metastatic disease

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

          -  At least 4 weeks since prior radiotherapy

          -  No concurrent radiotherapy

        Surgery

          -  Not specified

        Other

          -  At least 6 months since prior adjuvant therapy

          -  More than 4 weeks since prior investigational drugs

          -  No concurrent sorivudine or chemically related analogues (e.g., brivudine)

          -  No other concurrent investigational drugs

          -  No other concurrent cytotoxic agents

          -  No concurrent prophylactic fluconazole

          -  No concurrent or planned cyclo-oxygenase-2 (COX-2) inhibitors or nonsteroidal
             anti-inflammatory drugs

          -  No concurrent chronic use of full-dose aspirin (325 mg/day or greater)

               -  Concurrent low-dose (cardioprotective) aspirin prophylaxis (no more than 325 mg
                  every other day OR no more than 162.5 mg per day) allowed