{
    "info": {
        "nct_id": "NCT00025194",
        "official_title": "A Phase I And Randomized Phase 2 Trial Of Epothilone B Analogue BMS 247550 (NSC # 710428) Administered Every 21 Days With Or Without Oral Estramustine Phosphate In Patients With Androgen Independent Prostate Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* Must have disease progression meeting 1 of the following criteria:\n\n  * Rising prostate-specific antigen (PSA) on at least 3 consecutive measurements taken more than 1 week apart\n  * Measurable disease, defined as new or progressive soft tissue masses on CT scan or MRI\n  * New metastatic lesions by radionuclide bone scan\n* The most recent PSA must be at least 4 ng/mL if no measurable disease is present\n* Ineligible if sole manifestation of progressive disease is an increase in disease-related symptoms\n* Serum testosterone no greater than 50 ng/mL\n* One of the following therapies for maintenance of castrate status required:\n\n  * Must continue on gonadotropin-releasing hormone analogs (e.g., leuprolide or goserelin) to maintain castrate levels of serum testosterone\n\n    * Developed disease progression after discontinuation of the antiandrogen that was part of the first-line hormonal therapy\n  * Prior surgical orchiectomy\n* Developed disease progression after discontinuation of megestrol\n* No known brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 70-100%\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC at least 3,000/mm^3\n* Absolute neutrophil count at least 1,500/mm^3\n* Platelet count at least 100,000/mm^3\n* No history of bleeding disorder that would preclude anticoagulation with warfarin\n\nHepatic:\n\n* Bilirubin normal\n* AST/ALT no greater than 2.5 times upper limit of normal (ULN)\n* PT/PTT normal (unless anticoagulated for other reasons [e.g., atrial fibrillation])\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n\nCardiovascular:\n\n* No significant cardiovascular disease\n* No symptomatic congestive heart failure\n* No New York Heart Association class III or IV heart disease\n* No active unstable angina pectoris\n* No cardiac arrhythmia\n* No myocardial infarction within the past 6 months\n* No history of hemorrhagic or thrombotic cerebrovascular accident or deep venous thrombosis within the past 6 months\n\nPulmonary:\n\n* No pulmonary embolism within the past 6 months\n\nOther:\n\n* Fertile patients must use effective contraception\n* No history of allergic reactions to compounds of similar chemical or biological composition to the epothilones\n* No history of recent gastrointestinal bleeding that would preclude anticoagulation with warfarin\n* No other concurrent active malignancy except nonmelanomatous skin cancer\n\n  * Disease not considered currently active if completely treated with less than a 30% risk for relapse\n* No other concurrent uncontrolled illness\n* No ongoing or active infection\n* No psychiatric illness or social situation that would preclude study compliance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF) except for neutropenic fever\n* No concurrent immunotherapy\n\nChemotherapy:\n\n* No prior chemotherapy\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* See Disease Characteristics\n\nRadiotherapy:\n\n* No prior palliative radiotherapy to more than 25% of bone marrow\n* No prior radioisotope therapy with strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium\n* No concurrent therapeutic radiotherapy\n* Concurrent focal radiotherapy for palliation of bone disease-related symptoms allowed at the investigator's discretion\n\nSurgery:\n\n* See Disease Characteristics\n* At least 4 weeks since prior major surgery\n\nOther:\n\n* No other concurrent anticancer investigational or commercial agents or therapies\n* No concurrent herbal, alternative, or food supplements (e.g., PC-SPES, saw palmetto, or St. John's Wort)\n* No concurrent combination antiretroviral therapy for HIV-positive patients\n* No initiation of bisphosphonates immediately before or during study\n* Concurrent bisphosphonates allowed if developed disease progression while on stable doses\n* Concurrent daily multivitamin allowed"
    },
    "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 MALE",
            "criterions": [
                {
                    "exact_snippets": "MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "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 adenocarcinoma of the prostate",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have disease progression meeting 1 of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Must have disease progression",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Rising prostate-specific antigen (PSA) on at least 3 consecutive measurements taken more than 1 week apart",
            "criterions": [
                {
                    "exact_snippets": "Rising prostate-specific antigen (PSA) on at least 3 consecutive measurements",
                    "criterion": "prostate-specific antigen (PSA)",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "rising"
                        },
                        {
                            "requirement_type": "consecutive measurements",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "number of measurements",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "measurements"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "measurements taken more than 1 week apart",
                    "criterion": "measurement interval",
                    "requirements": [
                        {
                            "requirement_type": "time interval",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease, defined as new or progressive soft tissue masses on CT scan or MRI",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease, defined as new or progressive soft tissue masses on CT scan or MRI",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "new or progressive soft tissue masses on CT scan or MRI"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* New metastatic lesions by radionuclide bone scan",
            "criterions": [
                {
                    "exact_snippets": "New metastatic lesions by radionuclide bone scan",
                    "criterion": "metastatic lesions",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": "radionuclide bone scan"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "new"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The most recent PSA must be at least 4 ng/mL if no measurable disease is present",
            "criterions": [
                {
                    "exact_snippets": "most recent PSA must be at least 4 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "if no measurable disease is present",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ineligible if sole manifestation of progressive disease is an increase in disease-related symptoms",
            "criterions": [
                {
                    "exact_snippets": "sole manifestation of progressive disease is an increase in disease-related symptoms",
                    "criterion": "progressive disease manifestation",
                    "requirements": [
                        {
                            "requirement_type": "manifestation",
                            "expected_value": "increase in disease-related symptoms"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum testosterone no greater than 50 ng/mL",
            "criterions": [
                {
                    "exact_snippets": "Serum testosterone no greater than 50 ng/mL",
                    "criterion": "serum testosterone",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 50,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* One of the following therapies for maintenance of castrate status required:",
            "criterions": [
                {
                    "exact_snippets": "One of the following therapies for maintenance of castrate status required",
                    "criterion": "maintenance of castrate status",
                    "requirements": [
                        {
                            "requirement_type": "therapy",
                            "expected_value": "required"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must continue on gonadotropin-releasing hormone analogs (e.g., leuprolide or goserelin) to maintain castrate levels of serum testosterone",
            "criterions": [
                {
                    "exact_snippets": "Must continue on gonadotropin-releasing hormone analogs (e.g., leuprolide or goserelin)",
                    "criterion": "gonadotropin-releasing hormone analogs",
                    "requirements": [
                        {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "maintain castrate levels of serum testosterone",
                    "criterion": "serum testosterone",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "castrate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Developed disease progression after discontinuation of the antiandrogen that was part of the first-line hormonal therapy",
            "criterions": [
                {
                    "exact_snippets": "Developed disease progression",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "discontinuation of the antiandrogen",
                    "criterion": "antiandrogen discontinuation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "first-line hormonal therapy",
                    "criterion": "first-line hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior surgical orchiectomy",
            "criterions": [
                {
                    "exact_snippets": "Prior surgical orchiectomy",
                    "criterion": "surgical orchiectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Developed disease progression after discontinuation of megestrol",
            "criterions": [
                {
                    "exact_snippets": "Developed disease progression",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "discontinuation of megestrol",
                    "criterion": "discontinuation of megestrol",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known brain metastases",
            "criterions": [
                {
                    "exact_snippets": "No known brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "Performance status:",
            "criterions": [
                {
                    "exact_snippets": "Performance status:",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky 70-100%",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky 70-100%",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 70,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WBC at least 3,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "WBC at least 3,000/mm^3",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* No history of bleeding disorder that would preclude anticoagulation with warfarin",
            "criterions": [
                {
                    "exact_snippets": "No history of bleeding disorder",
                    "criterion": "bleeding disorder",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "that would preclude anticoagulation with warfarin",
                    "criterion": "anticoagulation with warfarin",
                    "requirements": [
                        {
                            "requirement_type": "preclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic:",
            "criterions": [
                {
                    "exact_snippets": "Hepatic:",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin normal",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin normal",
                    "criterion": "bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST/ALT no greater than 2.5 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "AST/ALT no greater than 2.5 times upper limit of normal (ULN)",
                    "criterion": "AST/ALT levels",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PT/PTT normal (unless anticoagulated for other reasons [e.g., atrial fibrillation])",
            "criterions": [
                {
                    "exact_snippets": "PT/PTT normal",
                    "criterion": "PT/PTT",
                    "requirements": [
                        {
                            "requirement_type": "normality",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal:",
            "criterions": [
                {
                    "exact_snippets": "Renal:",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine no greater than 1.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Creatinine no greater than 1.5 times ULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cardiovascular:",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular:",
                    "criterion": "cardiovascular condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No significant cardiovascular disease",
            "criterions": [
                {
                    "exact_snippets": "No significant cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No symptomatic congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "No symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No New York Heart Association class III or IV heart disease",
            "criterions": [
                {
                    "exact_snippets": "No New York Heart Association class III or IV heart disease",
                    "criterion": "New York Heart Association heart disease class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "!=",
                                "value": 3,
                                "unit": "class"
                            }
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "!=",
                                "value": 4,
                                "unit": "class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active unstable angina pectoris",
            "criterions": [
                {
                    "exact_snippets": "No active unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No cardiac arrhythmia",
            "criterions": [
                {
                    "exact_snippets": "No cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No myocardial infarction within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "No myocardial infarction within the past 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since last event",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of hemorrhagic or thrombotic cerebrovascular accident or deep venous thrombosis within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "No history of hemorrhagic ... cerebrovascular accident",
                    "criterion": "hemorrhagic cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of ... thrombotic cerebrovascular accident",
                    "criterion": "thrombotic cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of ... deep venous thrombosis within the past 6 months",
                    "criterion": "deep venous thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Pulmonary:",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary:",
                    "criterion": "pulmonary",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "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": "time since last occurrence",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 history of allergic reactions to compounds of similar chemical or biological composition to the epothilones",
            "criterions": [
                {
                    "exact_snippets": "No history of allergic reactions to compounds of similar chemical or biological composition to the epothilones",
                    "criterion": "allergic reactions",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "composition",
                            "expected_value": "similar chemical or biological composition to the epothilones"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of recent gastrointestinal bleeding that would preclude anticoagulation with warfarin",
            "criterions": [
                {
                    "exact_snippets": "No history of recent gastrointestinal bleeding",
                    "criterion": "gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "recency",
                            "expected_value": "recent"
                        }
                    ]
                },
                {
                    "exact_snippets": "that would preclude anticoagulation with warfarin",
                    "criterion": "anticoagulation with warfarin",
                    "requirements": [
                        {
                            "requirement_type": "preclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent active malignancy except nonmelanomatous skin cancer",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent active malignancy",
                    "criterion": "concurrent active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except nonmelanomatous skin cancer",
                    "criterion": "nonmelanomatous skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease not considered currently active if completely treated with less than a 30% risk for relapse",
            "criterions": [
                {
                    "exact_snippets": "Disease not considered currently active if completely treated",
                    "criterion": "disease activity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not active"
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "completely treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "less than a 30% risk for relapse",
                    "criterion": "risk for relapse",
                    "requirements": [
                        {
                            "requirement_type": "risk percentage",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent uncontrolled illness",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent uncontrolled illness",
                    "criterion": "concurrent uncontrolled illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No ongoing or active infection",
            "criterions": [
                {
                    "exact_snippets": "No ongoing or active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No psychiatric illness or social situation that would preclude study compliance",
            "criterions": [
                {
                    "exact_snippets": "No psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... social situation that would preclude study compliance",
                    "criterion": "social situation",
                    "requirements": [
                        {
                            "requirement_type": "impact on study compliance",
                            "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 routine filgrastim (G-CSF) or sargramostim (GM-CSF) except for neutropenic fever",
            "criterions": [
                {
                    "exact_snippets": "No concurrent routine filgrastim (G-CSF)",
                    "criterion": "concurrent routine filgrastim (G-CSF)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent routine ... sargramostim (GM-CSF)",
                    "criterion": "concurrent routine sargramostim (GM-CSF)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for neutropenic fever",
                    "criterion": "neutropenic fever",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent immunotherapy",
            "criterions": [
                {
                    "exact_snippets": "No concurrent immunotherapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chemotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "See Disease Characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Radiotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior palliative radiotherapy to more than 25% of bone marrow",
            "criterions": [
                {
                    "exact_snippets": "No prior palliative radiotherapy to more than 25% of bone marrow",
                    "criterion": "prior palliative radiotherapy to bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": "<=",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior radioisotope therapy with strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium",
            "criterions": [
                {
                    "exact_snippets": "No prior radioisotope therapy with strontium chloride Sr 89",
                    "criterion": "prior radioisotope therapy with strontium chloride Sr 89",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior radioisotope therapy with ... samarium Sm 153 lexidronam pentasodium",
                    "criterion": "prior radioisotope therapy with samarium Sm 153 lexidronam pentasodium",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent therapeutic radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "No concurrent therapeutic radiotherapy",
                    "criterion": "therapeutic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent focal radiotherapy for palliation of bone disease-related symptoms allowed at the investigator's discretion",
            "criterions": [
                {
                    "exact_snippets": "Concurrent focal radiotherapy for palliation of bone disease-related symptoms",
                    "criterion": "concurrent focal radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "palliation of bone disease-related symptoms"
                        }
                    ]
                },
                {
                    "exact_snippets": "at the investigator's discretion",
                    "criterion": "investigator's discretion",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery:",
            "criterions": [
                {
                    "exact_snippets": "Surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks since prior major surgery",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since prior major surgery",
                    "criterion": "time since major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent anticancer investigational or commercial agents or therapies",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent anticancer investigational or commercial agents or therapies",
                    "criterion": "concurrent anticancer agents or therapies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent herbal, alternative, or food supplements (e.g., PC-SPES, saw palmetto, or St. John's Wort)",
            "criterions": [
                {
                    "exact_snippets": "No concurrent herbal, alternative, or food supplements",
                    "criterion": "herbal, alternative, or food supplements",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "(e.g., PC-SPES, saw palmetto, or St. John's Wort)",
                    "criterion": "specific supplements",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent combination antiretroviral therapy for HIV-positive patients",
            "criterions": [
                {
                    "exact_snippets": "No concurrent combination antiretroviral therapy for HIV-positive patients",
                    "criterion": "combination antiretroviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No initiation of bisphosphonates immediately before or during study",
            "criterions": [
                {
                    "exact_snippets": "No initiation of bisphosphonates immediately before or during study",
                    "criterion": "initiation of bisphosphonates",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "not immediately before or during study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent bisphosphonates allowed if developed disease progression while on stable doses",
            "criterions": [
                {
                    "exact_snippets": "Concurrent bisphosphonates allowed",
                    "criterion": "concurrent bisphosphonates",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "developed disease progression while on stable doses",
                    "criterion": "disease progression on stable doses",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "developed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent daily multivitamin allowed",
            "criterions": [
                {
                    "exact_snippets": "Concurrent daily multivitamin allowed",
                    "criterion": "multivitamin use",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other:",
            "criterions": [
                {
                    "exact_snippets": "Tissue from tumor must be available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Other:",
            "criterions": []
        }
    ]
}