Clinical trial NCT00719797 (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, irinotecan hydrochloride, leucovorin calcium, oxaliplatin
SMILES: [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, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed colorectal cancer

               -  Unresectable metastatic disease

          -  Measurable disease, defined as ≥ 1 measurable lesion according to RECIST criteria

          -  No prior chemotherapy for metastatic disease

          -  No untreated brain metastases, spinal cord compression, or primary brain tumors

          -  No history or evidence of CNS disease by physical examination unless adequately
             treated (e.g., uncontrolled seizure despite standard medical therapy or history of
             stroke)

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  ECOG performance status (PS) 0-2 (≤ 70 years of age) OR ECOG PS 0 (71-75 years of age)

          -  Life expectancy ≥ 12 weeks

          -  Neutrophils ≥ 1.5 x 10^9/L

          -  Platelet count ≥ 100 x 10^9/L

          -  Hemoglobin > 9 g/dL

          -  Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN if f liver metastases present)

          -  Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases present)

          -  Creatinine clearance > 50 mL/min OR serum creatinine ≤ 1.5 times ULN

          -  Proteinuria < 2+ by dipstick OR urine protein ≤ 1 g by 24-hr urine collection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        Exclusion criteria:

          -  Serious, nonhealing wound, ulcer, or bone fracture

          -  Evidence of bleeding diathesis or coagulopathy

          -  Uncontrolled hypertension

          -  Clinically significant (i.e., active) cardiovascular disease, including any of the
             following:

               -  Cerebrovascular accidents within the past 6 months

               -  Myocardial infarction within the past 6 months

               -  Unstable angina

               -  New York Heart Association class II-IV congestive heart failure

               -  Serious cardiac arrhythmia requiring medication

          -  Known allergy to Chinese hamster ovary cell proteins or any of the components of the
             study medications

          -  Other co-existing malignancy or malignancy diagnosed within the past 5 years, except
             for basal cell or squamous cell carcinoma, or carcinoma in situ of the cervix

          -  Symptomatic peripheral neuropathy ≥ grade 1 according to the NCI Common Toxicity
             Criteria

          -  Lack of physical integrity of the upper gastrointestinal tract

          -  Malabsorption syndrome

          -  Inability to take oral medication

          -  Significant traumatic injury within the past 28 days

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 4 weeks since prior radiotherapy

          -  More than 10 days since prior and no concurrent ongoing treatment with anticoagulants
             for therapeutic purposes

          -  More than 28 days since prior and no concurrent major surgical procedure

          -  More than 28 days since prior open biopsy

          -  More than 30 days since prior investigational agents

          -  No concurrent chronic daily high-dose acetylsalicylic acid (> 325 mg/day)