{
    "info": {
        "nct_id": "NCT00320073",
        "official_title": "A Two Arm Phase I Dose Escalation Trial of Vinflunine With Erlotinib or Pemetrexed in Refractory Solid Tumors",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed solid tumors\n\n  * Advanced/unresectable or metastatic disease\n* Refractory to standard therapy OR no standard therapy exists\n* No lymphoma\n* Measurable or evaluable disease\n\n  * Measurable disease is defined as at least one target lesion measuring ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan\n  * Evaluable disease includes ascites, pleural effusion, bone metastases, pulmonary lymphangitic spread, and lesions not meeting above criteria as measurable\n\n    * Patients with clinically significant ascites or pleural effusions that cannot be controlled by drainage are not eligible\n* Brain metastases allowed if CNS-directed treatment has been given, patient has been off CNS-directed therapy for > 3 months, and CNS disease has been clinically and radiographically stable for at least 8 weeks\n\nPATIENT CHARACTERISTICS:\n\n* Life expectancy > 3 months\n* ECOG performance status 0-2\n* Absolute neutrophil count ≥ 1,500/μL\n* Platelet count ≥ 100,000/μL\n* Creatinine clearance ≥ 60 mL/min\n\n  * Patients assigned to group 1 with creatinine clearance 45-80 mL/min must be able to withhold NSAIDS during pemetrexed disodium administration\n* Total bilirubin ≤ 1.5 mg/dL\n* AST and ALT ≤ 3 times upper limit of normal (ULN) OR ≤ 5 times ULN if due to known liver metastases\n* No New York Heart Association class III or IV heart failure\n* No unstable angina\n* No myocardial infarction within the past 6 months\n* No poorly controlled hypertension\n* No prior allergic reaction to any vinca alkaloid\n* No uncontrolled active infection or severe illness\n* Able to receive vitamin B12 and folate supplementation and dexamethasone during chemotherapy\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 3 months after last dose of chemotherapy\n\nPRIOR CONCURRENT THERAPY:\n\n* At least 4 weeks since prior chemotherapy, investigational agents, or surgery\n* Concurrent cytochrome P450/CYP3A4 inducers or inhibitors are allowed provided patient has been on a stable dose for ≥ 2 weeks prior to study entry\n* No concurrent ketoconazole, itraconazole, ritonavir, amprenavir, or indinavir\n* No concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (e.g., phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine) for patients assigned to group 2"
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "DISEASE CHARACTERISTICS:",
                "criterions": [
                    {
                        "exact_snippets": "DISEASE CHARACTERISTICS",
                        "criterion": "disease characteristics",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "DISEASE CHARACTERISTICS",
                        "criterion": "disease characteristics",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Histologically confirmed solid tumors",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed solid tumors",
                        "criterion": "solid tumors",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histologically confirmed solid tumors",
                        "criterion": "solid tumors",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Advanced/unresectable or metastatic disease",
                "criterions": [
                    {
                        "exact_snippets": "Advanced/unresectable",
                        "criterion": "disease stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "unresectable"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "metastatic disease",
                        "criterion": "disease stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Advanced/unresectable",
                                "criterion": "disease stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "advanced",
                                        "unresectable"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "metastatic disease",
                        "criterion": "disease stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Refractory to standard therapy OR no standard therapy exists",
                "criterions": [
                    {
                        "exact_snippets": "Refractory to standard therapy",
                        "criterion": "refractory to standard therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "no standard therapy exists",
                        "criterion": "standard therapy availability",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Refractory to standard therapy",
                        "criterion": "refractory to standard therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "no standard therapy exists",
                        "criterion": "standard therapy availability",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No lymphoma",
                "criterions": [
                    {
                        "exact_snippets": "No lymphoma",
                        "criterion": "lymphoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No lymphoma",
                        "criterion": "lymphoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Measurable disease is defined as at least one target lesion measuring ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan",
                "criterions": [
                    {
                        "exact_snippets": "Measurable disease is defined as at least one target lesion measuring ≥ 20 mm by conventional techniques",
                        "criterion": "target lesion size by conventional techniques",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Measurable disease is defined as at least one target lesion measuring ... ≥ 10 mm by spiral CT scan",
                        "criterion": "target lesion size by spiral CT scan",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Measurable disease is defined as at least one target lesion measuring ≥ 20 mm by conventional techniques",
                        "criterion": "target lesion size by conventional techniques",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Measurable disease is defined as at least one target lesion measuring ... ≥ 10 mm by spiral CT scan",
                        "criterion": "target lesion size by spiral CT scan",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Evaluable disease includes ascites, pleural effusion, bone metastases, pulmonary lymphangitic spread, and lesions not meeting above criteria as measurable",
                "criterions": [
                    {
                        "exact_snippets": "Evaluable disease includes ascites",
                        "criterion": "ascites",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Evaluable disease includes ... pleural effusion",
                        "criterion": "pleural effusion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Evaluable disease includes ... bone metastases",
                        "criterion": "bone metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Evaluable disease includes ... pulmonary lymphangitic spread",
                        "criterion": "pulmonary lymphangitic spread",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Evaluable disease includes ... lesions not meeting above criteria as measurable",
                        "criterion": "lesions not meeting above criteria as measurable",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Evaluable disease includes ascites",
                        "criterion": "ascites",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Evaluable disease includes ... pleural effusion",
                        "criterion": "pleural effusion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Evaluable disease includes ... bone metastases",
                        "criterion": "bone metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Evaluable disease includes ... pulmonary lymphangitic spread",
                        "criterion": "pulmonary lymphangitic spread",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Evaluable disease includes ... lesions not meeting above criteria as measurable",
                        "criterion": "lesions not meeting above criteria as measurable",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with clinically significant ascites or pleural effusions that cannot be controlled by drainage are not eligible",
                "criterions": [
                    {
                        "exact_snippets": "clinically significant ascites",
                        "criterion": "ascites",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "pleural effusions",
                        "criterion": "pleural effusions",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "cannot be controlled by drainage",
                        "criterion": "control by drainage",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "clinically significant ascites",
                                "criterion": "ascites",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "clinically significant"
                                }
                            },
                            {
                                "exact_snippets": "cannot be controlled by drainage",
                                "criterion": "control by drainage",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "pleural effusions",
                                "criterion": "pleural effusions",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "clinically significant"
                                }
                            },
                            {
                                "exact_snippets": "cannot be controlled by drainage",
                                "criterion": "control by drainage",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Brain metastases allowed if CNS-directed treatment has been given, patient has been off CNS-directed therapy for > 3 months, and CNS disease has been clinically and radiographically stable for at least 8 weeks",
                "criterions": [
                    {
                        "exact_snippets": "Brain metastases allowed",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "CNS-directed treatment has been given",
                        "criterion": "CNS-directed treatment",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "patient has been off CNS-directed therapy for > 3 months",
                        "criterion": "CNS-directed therapy",
                        "requirement": {
                            "requirement_type": "duration off therapy",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "CNS disease has been clinically and radiographically stable for at least 8 weeks",
                        "criterion": "CNS disease stability",
                        "requirement": {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "CNS-directed treatment has been given",
                                "criterion": "CNS-directed treatment",
                                "requirement": {
                                    "requirement_type": "completion",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "patient has been off CNS-directed therapy for > 3 months",
                                "criterion": "CNS-directed therapy",
                                "requirement": {
                                    "requirement_type": "duration off therapy",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "CNS disease has been clinically and radiographically stable for at least 8 weeks",
                                "criterion": "CNS disease stability",
                                "requirement": {
                                    "requirement_type": "stability duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 8,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Brain metastases allowed",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Life expectancy > 3 months",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy > 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy > 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ECOG performance status 0-2",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG performance status 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count ≥ 1,500/μL",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count ≥ 1,500/μL",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "μL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count ≥ 1,500/μL",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "μL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count ≥ 100,000/μL",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count ≥ 100,000/μL",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "μL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelet count ≥ 100,000/μL",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "μL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Creatinine clearance ≥ 60 mL/min",
                "criterions": [
                    {
                        "exact_snippets": "Creatinine clearance ≥ 60 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Creatinine clearance ≥ 60 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients assigned to group 1 with creatinine clearance 45-80 mL/min must be able to withhold NSAIDS during pemetrexed disodium administration",
                "criterions": [
                    {
                        "exact_snippets": "Patients assigned to group 1",
                        "criterion": "group assignment",
                        "requirement": {
                            "requirement_type": "group",
                            "expected_value": "1"
                        }
                    },
                    {
                        "exact_snippets": "creatinine clearance 45-80 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 45,
                                        "unit": "mL/min"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "mL/min"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "must be able to withhold NSAIDS during pemetrexed disodium administration",
                        "criterion": "ability to withhold NSAIDS",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Patients assigned to group 1",
                            "criterion": "group assignment",
                            "requirement": {
                                "requirement_type": "group",
                                "expected_value": "1"
                            }
                        },
                        {
                            "exact_snippets": "creatinine clearance 45-80 mL/min",
                            "criterion": "creatinine clearance",
                            "requirement": {
                                "requirement_type": "range",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": ">=",
                                            "value": 45,
                                            "unit": "mL/min"
                                        },
                                        {
                                            "operator": "<=",
                                            "value": 80,
                                            "unit": "mL/min"
                                        }
                                    ]
                                }
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "must be able to withhold NSAIDS during pemetrexed disodium administration",
                    "criterion": "ability to withhold NSAIDS",
                    "requirement": {
                        "requirement_type": "ability",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* AST and ALT ≤ 3 times upper limit of normal (ULN) OR ≤ 5 times ULN if due to known liver metastases",
                "criterions": [
                    {
                        "exact_snippets": "AST and ALT ≤ 3 times upper limit of normal (ULN) OR ≤ 5 times ULN if due to known liver metastases",
                        "criterion": "AST and ALT levels",
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                            "requirement_type": "level",
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                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "times ULN"
                                    }
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                            }
                        }
                    },
                    {
                        "exact_snippets": "AST and ALT ≤ 3 times upper limit of normal (ULN) OR ≤ 5 times ULN if due to known liver metastases",
                        "criterion": "AST and ALT levels",
                        "requirement": {
                            "requirement_type": "level with liver metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        }
                    }
                ]
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            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "AST and ALT ≤ 3 times upper limit of normal (ULN) OR ≤ 5 times ULN if due to known liver metastases",
                                "criterion": "AST and ALT levels",
                                "requirement": {
                                    "requirement_type": "level",
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                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 3,
                                                "unit": "times ULN"
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                                }
                            },
                            {
                                "exact_snippets": "AST and ALT ≤ 3 times upper limit of normal (ULN) OR ≤ 5 times ULN if due to known liver metastases",
                                "criterion": "AST and ALT levels",
                                "requirement": {
                                    "requirement_type": "level with liver metastases",
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                                            {
                                                "operator": "<=",
                                                "value": 5,
                                                "unit": "times ULN"
                                            }
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                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No New York Heart Association class III or IV heart failure",
                "criterions": [
                    {
                        "exact_snippets": "No New York Heart Association class III or IV heart failure",
                        "criterion": "New York Heart Association heart failure class",
                        "requirement": {
                            "requirement_type": "severity",
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                                "operator": "!=",
                                "value": 3,
                                "unit": "class"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No New York Heart Association class III or IV heart failure",
                        "criterion": "New York Heart Association heart failure class",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "!=",
                                "value": 4,
                                "unit": "class"
                            }
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No New York Heart Association class III or IV heart failure",
                        "criterion": "New York Heart Association heart failure class",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "!=",
                                "value": 3,
                                "unit": "class"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No New York Heart Association class III or IV heart failure",
                        "criterion": "New York Heart Association heart failure class",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "!=",
                                "value": 4,
                                "unit": "class"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No myocardial infarction within the past 6 months",
                "criterions": [
                    {
                        "exact_snippets": "No myocardial infarction within the past 6 months",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since last event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No myocardial infarction within the past 6 months",
                    "criterion": "myocardial infarction",
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                        "requirement_type": "time since last event",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 6,
                                    "unit": "months"
                                }
                            ]
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* No prior allergic reaction to any vinca alkaloid",
                "criterions": [
                    {
                        "exact_snippets": "No prior allergic reaction to any vinca alkaloid",
                        "criterion": "allergic reaction to vinca alkaloid",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No prior allergic reaction to any vinca alkaloid",
                    "criterion": "allergic reaction to vinca alkaloid",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* No uncontrolled active infection or severe illness",
                "criterions": [
                    {
                        "exact_snippets": "No uncontrolled active infection",
                        "criterion": "active infection",
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                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... severe illness",
                        "criterion": "severe illness",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No uncontrolled active infection",
                        "criterion": "active infection",
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                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... severe illness",
                        "criterion": "severe illness",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Able to receive vitamin B12 and folate supplementation and dexamethasone during chemotherapy",
                "criterions": [
                    {
                        "exact_snippets": "Able to receive vitamin B12",
                        "criterion": "vitamin B12 supplementation",
                        "requirement": {
                            "requirement_type": "ability to receive",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Able to receive ... folate supplementation",
                        "criterion": "folate supplementation",
                        "requirement": {
                            "requirement_type": "ability to receive",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Able to receive ... dexamethasone during chemotherapy",
                        "criterion": "dexamethasone during chemotherapy",
                        "requirement": {
                            "requirement_type": "ability to receive",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Able to receive vitamin B12",
                        "criterion": "vitamin B12 supplementation",
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                            "requirement_type": "ability to receive",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Able to receive ... folate supplementation",
                        "criterion": "folate supplementation",
                        "requirement": {
                            "requirement_type": "ability to receive",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Able to receive ... dexamethasone during chemotherapy",
                        "criterion": "dexamethasone during chemotherapy",
                        "requirement": {
                            "requirement_type": "ability to receive",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Negative pregnancy test",
                "criterions": [
                    {
                        "exact_snippets": "Negative pregnancy test",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "test result",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Negative pregnancy test",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "test result",
                            "expected_value": "negative"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Fertile patients must use effective contraception during and for 3 months after last dose of chemotherapy",
                "criterions": [
                    {
                        "exact_snippets": "Fertile patients",
                        "criterion": "fertility",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must use effective contraception during and for 3 months after last dose of chemotherapy",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during and for 3 months after last dose of chemotherapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
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                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "exact_snippets": "must use effective contraception during and for 3 months after last dose of chemotherapy",
                    "criterion": "contraception use",
                    "requirement": {
                        "requirement_type": "duration",
                        "expected_value": "during and for 3 months after last dose of chemotherapy"
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "PRIOR CONCURRENT THERAPY:",
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                    {
                        "exact_snippets": "PRIOR CONCURRENT THERAPY",
                        "criterion": "prior concurrent therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "PRIOR CONCURRENT THERAPY",
                        "criterion": "prior concurrent therapy",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* At least 4 weeks since prior chemotherapy, investigational agents, or surgery",
                "criterions": [
                    {
                        "exact_snippets": "At least 4 weeks since prior chemotherapy",
                        "criterion": "time since prior chemotherapy",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 4 weeks since prior ... investigational agents",
                        "criterion": "time since prior investigational agents",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 4 weeks since prior ... surgery",
                        "criterion": "time since prior surgery",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "At least 4 weeks since prior chemotherapy",
                        "criterion": "time since prior chemotherapy",
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                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 4 weeks since prior ... investigational agents",
                        "criterion": "time since prior investigational agents",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 4 weeks since prior ... surgery",
                        "criterion": "time since prior surgery",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Concurrent cytochrome P450/CYP3A4 inducers or inhibitors are allowed provided patient has been on a stable dose for ≥ 2 weeks prior to study entry",
                "criterions": [
                    {
                        "exact_snippets": "Concurrent cytochrome P450/CYP3A4 inducers or inhibitors are allowed",
                        "criterion": "cytochrome P450/CYP3A4 inducers or inhibitors",
                        "requirement": {
                            "requirement_type": "concurrent use",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "provided patient has been on a stable dose for ≥ 2 weeks prior to study entry",
                        "criterion": "stable dose duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Concurrent cytochrome P450/CYP3A4 inducers or inhibitors are allowed",
                    "criterion": "cytochrome P450/CYP3A4 inducers or inhibitors",
                    "requirement": {
                        "requirement_type": "concurrent use",
                        "expected_value": true
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                },
                "then_criteria": {
                    "exact_snippets": "provided patient has been on a stable dose for ≥ 2 weeks prior to study entry",
                    "criterion": "stable dose duration",
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                        "requirement_type": "duration",
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                            "operator": ">=",
                            "value": 2,
                            "unit": "weeks"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* No concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (e.g., phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine) for patients assigned to group 2",
                "criterions": [
                    {
                        "exact_snippets": "No concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (e.g., phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine)",
                        "criterion": "concurrent enzyme-inducing antiepileptic drugs (EIAEDs)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "for patients assigned to group 2",
                    "criterion": "patient group assignment",
                    "requirement": {
                        "requirement_type": "assignment",
                        "expected_value": "group 2"
                    }
                },
                "then_criteria": {
                    "exact_snippets": "No concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (e.g., phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine)",
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                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "PATIENT CHARACTERISTICS:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "* Not pregnant or nursing",
                "criterions": [
                    {
                        "exact_snippets": "Not pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "not ... nursing",
                        "criterion": "nursing",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Not pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "not ... nursing",
                        "criterion": "nursing",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No concurrent ketoconazole, itraconazole, ritonavir, amprenavir, or indinavir",
                "criterions": [
                    {
                        "exact_snippets": "No concurrent ketoconazole",
                        "criterion": "concurrent ketoconazole",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent itraconazole",
                        "criterion": "concurrent itraconazole",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent ritonavir",
                        "criterion": "concurrent ritonavir",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent amprenavir",
                        "criterion": "concurrent amprenavir",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent indinavir",
                        "criterion": "concurrent indinavir",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No concurrent ketoconazole",
                        "criterion": "concurrent ketoconazole",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent itraconazole",
                        "criterion": "concurrent itraconazole",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent ritonavir",
                        "criterion": "concurrent ritonavir",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent amprenavir",
                        "criterion": "concurrent amprenavir",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No concurrent indinavir",
                        "criterion": "concurrent indinavir",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "* Measurable or evaluable disease",
                "criterions": [
                    {
                        "exact_snippets": "Measurable or evaluable disease",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Measurable or evaluable disease",
                        "criterion": "disease",
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                            "requirement_type": "measurability",
                            "expected_value": "measurable"
                        }
                    },
                    {
                        "exact_snippets": "Measurable or evaluable disease",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": "evaluable"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Total bilirubin ≤ 1.5 mg/dL",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin ≤ 1.5 mg/dL",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Total bilirubin \u0010.5 mg/dL",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No unstable angina",
                "criterions": [
                    {
                        "exact_snippets": "No unstable angina",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No unstable angina",
                    "criterion": "unstable angina",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* No poorly controlled hypertension",
                "criterions": [
                    {
                        "exact_snippets": "No poorly controlled hypertension",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "not poorly controlled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No poorly controlled hypertension",
                    "criterion": "hypertension",
                    "requirement": {
                        "requirement_type": "control",
                        "expected_value": "poorly controlled"
                    }
                }
            }
        }
    ]
}