Clinical trial NCT00002570 (phase 3, status: completed)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: fluorouracil, leucovorin calcium
SMILES: [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 or cytologically confirmed cancer of the colon or
        rectum that is locally advanced or metastatic Primary lesion was or is located in the large
        bowel as confirmed by endoscopy, radiology, or surgery Radiologic or clinical evidence of
        metastasis subsequent to resection does not require histologic or cytologic confirmation
        unless: Interval between primary surgery and development of metastasis is greater than 5
        years OR Primary cancer was Dukes' A or B1 Ineligible for potentially curative therapy,
        e.g.: Surgical resection of a limited hepatic or pulmonary metastasis Irradiation of
        locally recurrent colon or rectal cancer No or minimal symptoms related to the cancer,
        i.e.: No persistent pain requiring regular narcotic analgesia No persistent fever greater
        than 38 degrees C No symptomatic bowel obstruction No persistent nausea requiring
        medication No weight loss of greater than 5 kg over the previous 3 months unless clearly
        not associated with the cancer (e.g., associated with surgery or intercurrent illness)
        Symptomatic relapse/metastases rendered asymptomatic by secondary surgery or radiotherapy
        are eligible provided the patient remains asymptomatic for at least 6 weeks following such
        treatment No CNS metastases No significant ascites, pleural effusion, or pericardial
        effusion

        PATIENT CHARACTERISTICS: Age: Adult under 80 (i.e., of legal age to sign own informed
        consent according to institutional policy) Performance status: Karnofsky 90-100% ECOG 0
        Hematopoietic: Granulocytes at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic:
        Bilirubin no greater than upper limit of normal Renal: Creatinine less than 2.26 mg/dL
        Cardiovascular: No arrhythmia Other: No infection No other medical condition that is
        uncontrolled or could be aggravated by the protocol therapy No prior or concurrent second
        cancer except: Nonmelanomatous skin cancer In situ cervical cancer No pregnant women
        Adequate contraception required of fertile patients Blood/body fluid analyses to determine
        eligibility and quality-of-life questionnaire completed within 14 days prior to
        randomization; imaging studies of sites of disease completed within 28 days prior to
        randomization

        PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
        chemotherapy for metastatic disease or local recurrence Prior fluorouracil-based or other
        adjuvant therapy allowed At least 6 months required between completion of therapy and
        documentation of metastasis or recurrence Endocrine therapy: Not specified Radiotherapy:
        Prior radiotherapy allowed Surgery: Prior surgery allowed