{
    "info": {
        "nct_id": "NCT00070031",
        "official_title": "A Phase II Study of Intravenous Edotecarin (PHA-782615) in Patients With Anthracycline- and Taxane-Refractory or Chemoresistant Metastatic Breast Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed primary adenocarcinoma of the breast\n\n  * Locally advanced or metastatic disease\n* Not amenable to surgery or radiotherapy with curative intent\n* At least 1 unidimensionally measurable lesion\n\n  * At least 20 mm by conventional techniques OR 10 mm by CT scan\n  * Not previously irradiated\n* Meets 1 of the following criteria:\n\n  * Previously treated with anthracycline and concurrent or sequential taxane therapy\n\n    * Refractory to the most recent taxane-based chemotherapy, defined as 1 of the following:\n\n      * Progressive disease during therapy or within 4 months of the last dose with or without documented response for advanced disease\n      * Progressive disease within 6 months of completing taxane-based chemotherapy as neoadjuvant therapy\n  * Resistant to prior chemotherapy, as defined by progressive disease within 6 months of completing prior chemotherapy for advanced disease\n* No known brain metastases or carcinomatous meningitis* NOTE: *Baseline CT scan or MRI of the brain required if there is clinical suspicion of CNS metastases\n* No spinal cord compression\n* Hormone receptor status:\n\n  * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nSex\n\n* Female\n\nMenopausal status\n\n* Not specified\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count at least 1,500/mm^3\n* Platelet count at least 100,000/mm^3\n* Hemoglobin at least 9.0 g/dL\n\nHepatic\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* SGOT no greater than 2.5 times ULN (5 times ULN if liver involvement secondary to tumor is present)\n* Albumin at least 3.0 g/dL\n\nRenal\n\n* Creatinine no greater than 1.5 mg/dL\n\nCardiovascular\n\n* LVEF at least 50% or ULN by echocardiogram or MUGA\n* None of the following within the past 6 months:\n\n  * Myocardial infarction\n  * Severe or unstable angina\n  * Symptomatic congestive heart failure\n  * Cerebrovascular accident or transient ischemic attack\n  * Deep vein thrombosis or other significant thromboembolic event\n* No ongoing cardiac dysrhythmias grade 2 or greater\n* No atrial fibrillation of any grade\n\nPulmonary\n\n* No pulmonary embolism within the past 6 months\n\nGastrointestinal\n\n* No active inflammatory bowel disease\n* No partial or complete bowel obstruction\n* No chronic diarrhea\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No known HIV positivity\n* No active infection\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n* No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation or confound study results\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent biological response modifiers\n* No concurrent immunotherapy\n* No concurrent sargramostim (GM-CSF)\n* No other concurrent granulocyte colony-stimulating factors\n\nChemotherapy\n\n* See Disease Characteristics\n* Prior adjuvant chemotherapy allowed\n* No prior topoisomerase I inhibitors\n* No more than 2 prior chemotherapy regimens for advanced disease\n* No prior high-dose chemotherapy that required hematopoietic stem cell rescue\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* Prior adjuvant hormonal therapy or hormonal therapy for advanced/metastatic disease allowed provided that therapy is discontinued before study entry\n* No concurrent hormonal therapy\n\nRadiotherapy\n\n* See Disease Characteristics\n* No prior radiotherapy to more than 25% of the bone marrow\n* No concurrent radiotherapy during and for 5 days after study treatment\n\n  * Palliative radiotherapy allowed provided no more than 20% of the bone marrow is involved\n\nSurgery\n\n* No coronary/peripheral artery bypass graft within the past 6 months\n\nOther\n\n* Recovered from prior therapy (except alopecia or neurotoxicity)\n* At least 4 weeks since any other prior therapy\n* More than 4 weeks since prior investigational agents\n* No concurrent enrollment on another clinical trial\n* No other concurrent approved or investigational anticancer treatment"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Histologically or cytologically confirmed primary adenocarcinoma of the breast",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed primary adenocarcinoma of the breast",
                    "criterion": "primary adenocarcinoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Locally advanced or metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Locally advanced",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not amenable to surgery or radiotherapy with curative intent",
            "criterions": [
                {
                    "exact_snippets": "Not amenable to surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Not amenable to ... radiotherapy with curative intent",
                    "criterion": "radiotherapy with curative intent",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 1 unidimensionally measurable lesion",
            "criterions": [
                {
                    "exact_snippets": "At least 1 unidimensionally measurable lesion",
                    "criterion": "unidimensionally measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 20 mm by conventional techniques OR 10 mm by CT scan",
            "criterions": [
                {
                    "exact_snippets": "At least 20 mm by conventional techniques",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "10 mm by CT scan",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not previously irradiated",
            "criterions": [
                {
                    "exact_snippets": "Not previously irradiated",
                    "criterion": "previous irradiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Meets 1 of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Meets 1 of the following criteria",
                    "criterion": "criteria",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "criteria"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previously treated with anthracycline and concurrent or sequential taxane therapy",
            "criterions": [
                {
                    "exact_snippets": "Previously treated with anthracycline",
                    "criterion": "anthracycline treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "concurrent or sequential taxane therapy",
                    "criterion": "taxane therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Refractory to the most recent taxane-based chemotherapy, defined as 1 of the following:",
            "criterions": [
                {
                    "exact_snippets": "Refractory to the most recent taxane-based chemotherapy",
                    "criterion": "refractory to taxane-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "refractory"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressive disease during therapy or within 4 months of the last dose with or without documented response for advanced disease",
            "criterions": [
                {
                    "exact_snippets": "Progressive disease during therapy",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Progressive disease ... within 4 months of the last dose",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 4 months of the last dose"
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without documented response for advanced disease",
                    "criterion": "documented response for advanced disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "with",
                                "without"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressive disease within 6 months of completing taxane-based chemotherapy as neoadjuvant therapy",
            "criterions": [
                {
                    "exact_snippets": "Progressive disease within 6 months of completing taxane-based chemotherapy as neoadjuvant therapy",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 6 months of completing taxane-based chemotherapy as neoadjuvant therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Resistant to prior chemotherapy, as defined by progressive disease within 6 months of completing prior chemotherapy for advanced disease",
            "criterions": [
                {
                    "exact_snippets": "Resistant to prior chemotherapy, as defined by progressive disease within 6 months of completing prior chemotherapy for advanced disease",
                    "criterion": "resistance to prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "progressive disease within 6 months of completing prior chemotherapy for advanced disease"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known brain metastases or carcinomatous meningitis* NOTE: *Baseline CT scan or MRI of the brain required if there is clinical suspicion of CNS metastases",
            "criterions": [
                {
                    "exact_snippets": "No known brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No known ... carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No spinal cord compression",
            "criterions": [
                {
                    "exact_snippets": "No spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormone receptor status:",
            "criterions": [
                {
                    "exact_snippets": "Hormone receptor status",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age",
            "criterions": [
                {
                    "exact_snippets": "Age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 and over",
            "criterions": [
                {
                    "exact_snippets": "18 and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Sex",
            "criterions": [
                {
                    "exact_snippets": "Sex",
                    "criterion": "sex",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Menopausal status",
            "criterions": [
                {
                    "exact_snippets": "Menopausal status",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Performance status",
            "criterions": [
                {
                    "exact_snippets": "Performance status",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Life expectancy",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hematopoietic",
            "criterions": [
                {
                    "exact_snippets": "Hematopoietic",
                    "criterion": "hematopoietic system",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count at least 1,500/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count at least 1,500/mm^3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count at least 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count at least 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin at least 9.0 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin at least 9.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic",
            "criterions": [
                {
                    "exact_snippets": "Hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin no greater than 1.5 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin no greater than 1.5 times upper limit of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* SGOT no greater than 2.5 times ULN (5 times ULN if liver involvement secondary to tumor is present)",
            "criterions": [
                {
                    "exact_snippets": "SGOT no greater than 2.5 times ULN",
                    "criterion": "SGOT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "5 times ULN if liver involvement secondary to tumor is present",
                    "criterion": "SGOT with liver involvement",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Albumin at least 3.0 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Albumin at least 3.0 g/dL",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal",
            "criterions": [
                {
                    "exact_snippets": "Renal",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine no greater than 1.5 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Creatinine no greater than 1.5 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cardiovascular",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular",
                    "criterion": "cardiovascular condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* LVEF at least 50% or ULN by echocardiogram or MUGA",
            "criterions": [
                {
                    "exact_snippets": "LVEF at least 50% or ULN by echocardiogram or MUGA",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": "=",
                                        "value": 50,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": "=",
                                        "value": 50,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* None of the following within the past 6 months:",
            "criterions": [
                {
                    "exact_snippets": "None of the following within the past 6 months",
                    "criterion": "recent medical events",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myocardial infarction",
            "criterions": [
                {
                    "exact_snippets": "Myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe or unstable angina",
            "criterions": [
                {
                    "exact_snippets": "Severe or unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "severe",
                                "unstable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cerebrovascular accident or transient ischemic attack",
            "criterions": [
                {
                    "exact_snippets": "Cerebrovascular accident",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "transient ischemic attack",
                    "criterion": "transient ischemic attack",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Deep vein thrombosis or other significant thromboembolic event",
            "criterions": [
                {
                    "exact_snippets": "Deep vein thrombosis",
                    "criterion": "deep vein thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other significant thromboembolic event",
                    "criterion": "thromboembolic event",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No ongoing cardiac dysrhythmias grade 2 or greater",
            "criterions": [
                {
                    "exact_snippets": "No ongoing cardiac dysrhythmias grade 2 or greater",
                    "criterion": "cardiac dysrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No atrial fibrillation of any grade",
            "criterions": [
                {
                    "exact_snippets": "No atrial fibrillation of any grade",
                    "criterion": "atrial fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Pulmonary",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary",
                    "criterion": "pulmonary condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No pulmonary embolism within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "No pulmonary embolism within the past 6 months",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Gastrointestinal",
            "criterions": [
                {
                    "exact_snippets": "Gastrointestinal",
                    "criterion": "gastrointestinal condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active inflammatory bowel disease",
            "criterions": [
                {
                    "exact_snippets": "No active inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No partial or complete bowel obstruction",
            "criterions": [
                {
                    "exact_snippets": "No partial or complete bowel obstruction",
                    "criterion": "bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No chronic diarrhea",
            "criterions": [
                {
                    "exact_snippets": "No chronic diarrhea",
                    "criterion": "chronic diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known HIV positivity",
            "criterions": [
                {
                    "exact_snippets": "No known HIV positivity",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "positivity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active infection",
            "criterions": [
                {
                    "exact_snippets": "No active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix",
            "criterions": [
                {
                    "exact_snippets": "No other malignancy within the past 5 years",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except adequately treated basal cell or squamous cell skin cancer",
                    "criterion": "basal cell or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment adequacy",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation or confound study results",
            "criterions": [
                {
                    "exact_snippets": "No other severe acute or chronic medical or psychiatric condition",
                    "criterion": "medical or psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe acute or chronic"
                        }
                    ]
                },
                {
                    "exact_snippets": "No other ... laboratory abnormality",
                    "criterion": "laboratory abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Biologic therapy",
            "criterions": [
                {
                    "exact_snippets": "Biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent biological response modifiers",
            "criterions": [
                {
                    "exact_snippets": "No concurrent biological response modifiers",
                    "criterion": "biological response modifiers",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent immunotherapy",
            "criterions": [
                {
                    "exact_snippets": "No concurrent immunotherapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent sargramostim (GM-CSF)",
            "criterions": [
                {
                    "exact_snippets": "No concurrent sargramostim (GM-CSF)",
                    "criterion": "sargramostim (GM-CSF)",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent granulocyte colony-stimulating factors",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent granulocyte colony-stimulating factors",
                    "criterion": "granulocyte colony-stimulating factors",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "see disease characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior adjuvant chemotherapy allowed",
            "criterions": [
                {
                    "exact_snippets": "Prior adjuvant chemotherapy allowed",
                    "criterion": "prior adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior topoisomerase I inhibitors",
            "criterions": [
                {
                    "exact_snippets": "No prior topoisomerase I inhibitors",
                    "criterion": "prior topoisomerase I inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No more than 2 prior chemotherapy regimens for advanced disease",
            "criterions": [
                {
                    "exact_snippets": "No more than 2 prior chemotherapy regimens for advanced disease",
                    "criterion": "prior chemotherapy regimens for advanced disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior high-dose chemotherapy that required hematopoietic stem cell rescue",
            "criterions": [
                {
                    "exact_snippets": "No prior high-dose chemotherapy",
                    "criterion": "high-dose chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "required hematopoietic stem cell rescue",
                    "criterion": "hematopoietic stem cell rescue",
                    "requirements": [
                        {
                            "requirement_type": "requirement for prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent chemotherapy",
                    "criterion": "concurrent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Endocrine therapy",
            "criterions": [
                {
                    "exact_snippets": "Endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior adjuvant hormonal therapy or hormonal therapy for advanced/metastatic disease allowed provided that therapy is discontinued before study entry",
            "criterions": [
                {
                    "exact_snippets": "Prior adjuvant hormonal therapy",
                    "criterion": "adjuvant hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hormonal therapy for advanced/metastatic disease",
                    "criterion": "hormonal therapy for advanced/metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent hormonal therapy",
            "criterions": [
                {
                    "exact_snippets": "No concurrent hormonal therapy",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "see disease characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior radiotherapy to more than 25% of the bone marrow",
            "criterions": [
                {
                    "exact_snippets": "No prior radiotherapy to more than 25% of the bone marrow",
                    "criterion": "prior radiotherapy to bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": "<=",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent radiotherapy during and for 5 days after study treatment",
            "criterions": [
                {
                    "exact_snippets": "No concurrent radiotherapy during and for 5 days after study treatment",
                    "criterion": "concurrent radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Palliative radiotherapy allowed provided no more than 20% of the bone marrow is involved",
            "criterions": [
                {
                    "exact_snippets": "Palliative radiotherapy allowed",
                    "criterion": "palliative radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no more than 20% of the bone marrow is involved",
                    "criterion": "bone marrow involvement",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": {
                                "operator": "<=",
                                "value": 20,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery",
            "criterions": [
                {
                    "exact_snippets": "Surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No coronary/peripheral artery bypass graft within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "No coronary/peripheral artery bypass graft within the past 6 months",
                    "criterion": "coronary/peripheral artery bypass graft",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recovered from prior therapy (except alopecia or neurotoxicity)",
            "criterions": [
                {
                    "exact_snippets": "Recovered from prior therapy",
                    "criterion": "recovery from prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                },
                {
                    "exact_snippets": "except alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... neurotoxicity",
                    "criterion": "neurotoxicity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks since any other prior therapy",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since any other prior therapy",
                    "criterion": "time since prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since prior investigational agents",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since prior investigational agents",
                    "criterion": "time since prior investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent enrollment on another clinical trial",
            "criterions": [
                {
                    "exact_snippets": "No concurrent enrollment on another clinical trial",
                    "criterion": "concurrent enrollment on another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent approved or investigational anticancer treatment",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent approved or investigational anticancer treatment",
                    "criterion": "concurrent anticancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other",
            "criterions": []
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Other",
            "criterions": []
        }
    ]
}