{
    "info": {
        "nct_id": "NCT00003160",
        "official_title": "A Phase II Trial of Paclitaxel (Taxol) Administered as a Weekly One Hour Infusion in Patients With Taxol/Platinum-Refractory Stage III and IV Ovarian Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian cancer that is refractory to an initial chemotherapy regimen that included a platinum agent plus paclitaxel - Epithelial ovarian cancer - Primary carcinoma of the peritoneum - Fallopian tube cancer Initial response to platinum and paclitaxel must have been one of the following: Progression or stable disease Response that lasted less than 3 months Response that lasted at least 3 months, but when retreated with both agents (in combination or as single agents) disease was refractory Measurable or evaluable disease Evaluable disease is defined by: CA-125 at least 100 units/mL AND CA-125 level must have at least doubled from baseline determination\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York Heart Association Class III or IV heart disease No myocardial infarction within last 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Neurology: No current peripheral neuropathy of any etiology that is greater than grade 1 Other: No active serious infection or other serious underlying medical condition No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporin, or vitamin K Not pregnant or nursing Adequate contraception required of all fertile patients\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since immunotherapy No concurrent immunotherapy Chemotherapy: Prior paclitaxel treatment must have been administered on a 3 week or greater schedule No other prior chemotherapy besides platinum and paclitaxel At least 3 weeks since acceptable chemotherapy Endocrine therapy: At least 3 weeks since hormonal therapy No concurrent hormonal therapy Radiotherapy: At least 3 weeks since radiotherapy No prior radiation to greater than 30% of bone marrow Surgery: At least 3 weeks since major surgery"
    },
    "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": "DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian cancer that is refractory to an initial chemotherapy regimen that included a platinum agent plus paclitaxel - Epithelial ovarian cancer - Primary carcinoma of the peritoneum - Fallopian tube cancer Initial response to platinum and paclitaxel must have been one of the following: Progression or stable disease Response that lasted less than 3 months Response that lasted at least 3 months, but when retreated with both agents (in combination or as single agents) disease was refractory Measurable or evaluable disease Evaluable disease is defined by: CA-125 at least 100 units/mL AND CA-125 level must have at least doubled from baseline determination",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed stage III or IV ovarian cancer",
                    "criterion": "ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        },
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically"
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to an initial chemotherapy regimen that included a platinum agent plus paclitaxel",
                    "criterion": "chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "refractory",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "components",
                            "expected_value": [
                                "platinum agent",
                                "paclitaxel"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Epithelial ovarian cancer",
                    "criterion": "epithelial ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Primary carcinoma of the peritoneum",
                    "criterion": "primary carcinoma of the peritoneum",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Fallopian tube cancer",
                    "criterion": "fallopian tube cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Initial response to platinum and paclitaxel must have been one of the following: Progression or stable disease",
                    "criterion": "initial response to platinum and paclitaxel",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "progression",
                                "stable disease"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Initial response to platinum and paclitaxel must have been one of the following: ... Response that lasted less than 3 months",
                    "criterion": "initial response to platinum and paclitaxel",
                    "requirements": [
                        {
                            "requirement_type": "response duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Initial response to platinum and paclitaxel must have been one of the following: ... Response that lasted at least 3 months, but when retreated with both agents (in combination or as single agents) disease was refractory",
                    "criterion": "initial response to platinum and paclitaxel",
                    "requirements": [
                        {
                            "requirement_type": "response duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        },
                        {
                            "requirement_type": "retreatment response",
                            "expected_value": "refractory"
                        }
                    ]
                },
                {
                    "exact_snippets": "Measurable or evaluable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Evaluable disease is defined by: CA-125 at least 100 units/mL",
                    "criterion": "CA-125 level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "units/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "CA-125 level must have at least doubled from baseline determination",
                    "criterion": "CA-125 level change",
                    "requirements": [
                        {
                            "requirement_type": "change",
                            "expected_value": "doubled from baseline"
                        }
                    ]
                }
            ]
        },
        {
            "line": "PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York Heart Association Class III or IV heart disease No myocardial infarction within last 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Neurology: No current peripheral neuropathy of any etiology that is greater than grade 1 Other: No active serious infection or other serious underlying medical condition No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporin, or vitamin K Not pregnant or nursing Adequate contraception required of all fertile patients",
            "criterions": [
                {
                    "exact_snippets": "Age: 18 and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: ECOG 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "ECOG"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Life expectancy: At least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: Absolute granulocyte count at least 1,500/mm3",
                    "criterion": "absolute granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count at least 100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST or ALT no greater than 2.5 times ULN",
                    "criterion": "AST or ALT level",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal: Creatinine no greater than 2.0 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiovascular: No New York Heart Association Class III or IV heart disease",
                    "criterion": "New York Heart Association heart disease class",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "Class III",
                                "Class IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "No myocardial infarction within last 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No clinically significant pericardial effusion or arrhythmia",
                    "criterion": "clinically significant pericardial effusion or arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Neurology: No current peripheral neuropathy of any etiology that is greater than grade 1",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: No active serious infection or other serious underlying medical condition",
                    "criterion": "active serious infection or other serious underlying medical condition",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporin, or vitamin K",
                    "criterion": "significant allergic reactions to drugs containing Cremophor",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Not pregnant or nursing",
                    "criterion": "pregnancy or nursing",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate contraception required of all fertile patients",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "adequate contraception"
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since immunotherapy No concurrent immunotherapy Chemotherapy: Prior paclitaxel treatment must have been administered on a 3 week or greater schedule No other prior chemotherapy besides platinum and paclitaxel At least 3 weeks since acceptable chemotherapy Endocrine therapy: At least 3 weeks since hormonal therapy No concurrent hormonal therapy Radiotherapy: At least 3 weeks since radiotherapy No prior radiation to greater than 30% of bone marrow Surgery: At least 3 weeks since major surgery",
            "criterions": [
                {
                    "exact_snippets": "At least 3 weeks since immunotherapy",
                    "criterion": "time since immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent immunotherapy",
                    "criterion": "concurrent immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior paclitaxel treatment must have been administered on a 3 week or greater schedule",
                    "criterion": "paclitaxel treatment schedule",
                    "requirements": [
                        {
                            "requirement_type": "schedule",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No other prior chemotherapy besides platinum and paclitaxel",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "allowed treatments",
                            "expected_value": [
                                "platinum",
                                "paclitaxel"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 3 weeks since acceptable chemotherapy",
                    "criterion": "time since acceptable chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 3 weeks since hormonal therapy",
                    "criterion": "time since hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent hormonal therapy",
                    "criterion": "concurrent hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 3 weeks since radiotherapy",
                    "criterion": "time since radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior radiation to greater than 30% of bone marrow",
                    "criterion": "prior radiation to bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "extent of radiation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 3 weeks since major surgery",
                    "criterion": "time since major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}