Clinical trial NCT00602329 (phase 2, status: terminated)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: fluorouracil, leucovorin calcium, oxaliplatin
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, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    due to poor accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed advanced or metastatic adenocarcinoma of the colon or rectum

          -  Patients receiving bevacizumab must have tumor tissue available for
             immunohistochemical analysis

               -  Formalin-fixed, paraffin-embedded tissue from previous biopsy or surgical
                  resection is sufficient

          -  Measurable disease, defined by RECIST as ≥ 1 lesion that can be accurately measured in
             ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques
             (i.e., CT or MRI)

               -  CEA elevation alone is insufficient for study entry

          -  No known brain metastases

        PATIENT CHARACTERISTICS:

        Criteria for all patients

          -  ECOG performance status 0-1

          -  Life expectancy > 3 months

          -  Granulocytes ≥ 1,500/mL

          -  Platelet Count ≥ 100,000/mL

          -  Creatinine ≤ 1.5 times upper limit of normal (ULN)

          -  Bilirubin ≤ 1.5 times ULN

          -  AST ≤ 5 times ULN

          -  Urine protein:creatinine ratio ≤ 1.0 at screening

          -  Patients with other prior malignancies are eligible, provided they have been treated
             with curative intent and have no evidence of recurrence

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  No contraindications to MRI, including any of the following:

               -  Hypersensitivity to gadolinium

               -  Metallic device, including pacemaker, non-MRI compatible aneurysm clip, other
                  non-MRI-compatible mechanical and/or electrical device, or metallic fragments

               -  Severe claustrophobia

        Additional criteria for patients receiving bevacizumab:

          -  No significant traumatic injury within the past 28 days

          -  No serious nonhealing wounds, ulcers, or bone fractures

          -  No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
             the past 6 months

          -  No myocardial infarction, unstable angina, or cerebrovascular accident within the past
             6 months

          -  No clinically significant peripheral vascular disease

          -  No New York Heart Association class II-IV congestive heart failure

          -  Patients with pre-existing hypertension should be on a stable antihypertensive regimen
             with blood pressure ≤ 150/100 mm Hg at study entry

        PRIOR CONCURRENT THERAPY:

        Criteria for all patients

          -  Prior adjuvant treatment including oxaliplatin allowed

          -  No prior bevacizumab

          -  At least 14 days since prior radiotherapy and recovered

          -  More than 6 months since prior chemotherapy

          -  No other concurrent investigational agents

        Additional criteria for patients receiving bevacizumab:

          -  At least 28 days since prior major surgical procedure or open biopsy

          -  At least 7 days since prior minor surgical procedure (e.g., fine-needle aspirations or
             core biopsies)

          -  No anticipation of need for a major surgical procedure during study treatment

          -  Concurrent oral or parenteral anticoagulation therapy allowed provided dose is stable