Clinical trial NCT00098787 (phase 2, 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:

        INCLUSION:

          -  Metastatic or locally recurrent colorectal adenocarcinoma

          -  Measurable disease

          -  At least 2 formalin-fixed paraffin embedded core needle biopsies OR fine needle
             aspirate containing a minimum of 3 clusters of malignant cells and fixed tissue from
             the previous biopsy

          -  If no tissue samples are available the patient must be willing to undergo biopsy of a
             metastatic site

          -  Age 18 and over

          -  Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Prothrombin time (PT)/international normalized ratio (INR) ≤ 1.5 unless patient is
             receiving full-dose anticoagulants AND the following criteria are met:

               -  In-range INR (usually between 2 and 3) AND on a stable dose of warfarin or low
                  molecular weight heparin

               -  No active bleeding or pathological condition that is associated with a high risk
                  of bleeding

          -  Partial thromboplastin time (PTT) < 1.5 times upper limit of normal (ULN)

          -  Alanine transaminase (ALT) and aspartate aminotransferase (AST) < 3 times ULN

          -  Bilirubin ≤ 1.5 times ULN

          -  Creatinine ≤ 1.8 mg/dL

          -  Meets 1 of the following criteria:

               -  Protein negative on urine dipstick

               -  Urine protein/creatinine ratio < 1.0

               -  Less than 2 g protein on 24-hour urine collection

          -  Patients with a history of hypertension must meet the following criteria:

               -  Blood pressure < 150/90 mm Hg

               -  Stable regimen of anti-hypertensive therapy

          -  More than 28 days since prior major or open surgery

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after study
             participation

          -  Prior non-colorectal malignancies are allowed provided the following criteria are met:

               -  No current clinical evidence of persistent or recurrent disease

               -  No active therapy for non-colorectal malignancy, including hormonal therapy

        EXCLUSION:

          -  Pregnant or nursing

          -  Arterial thromboembolic events within the past 6 months, including the following:

               -  Transient ischemic attack

               -  Cerebrovascular accident

               -  Unstable angina pectoris

               -  Myocardial infarction

          -  Symptomatic arrhythmia

          -  Symptomatic congestive heart failure

          -  Clinically significant peripheral artery disease

          -  New York Heart Association class III or IV heart disease

          -  Serious nonhealing wound, ulcer, or bone fracture within the past 28 days

          -  Significant traumatic injury within the past 28 days

          -  Neuropathy ≥ grade 2

          -  Ongoing or active infection

          -  Concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

          -  Prior chemotherapy for metastatic disease. Adjuvant therapy completed at least 12
             months before first evidence of metastasis allowed

          -  Cardiovascular, renal, hepatic, or other nonmalignant systemic disease that would
             preclude study therapy