[96a5a0]: / output / allTrials / logical / NCT00003160_logical.json

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{
"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": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "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",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "Performance status: ECOG 0-2",
"criterion": "performance status",
"requirement": {
"requirement_type": "scale",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "ECOG"
}
}
},
{
"exact_snippets": "Life expectancy: At least 3 months",
"criterion": "life expectancy",
"requirement": {
"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",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm3"
}
}
},
{
"exact_snippets": "Platelet count at least 100,000/mm3",
"criterion": "platelet count",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"requirement_type": "exclusion",
"expected_value": [
"Class III",
"Class IV"
]
}
},
{
"exact_snippets": "No myocardial infarction within last 6 months",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "recency",
"expected_value": {
"operator": ">",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "No congestive heart failure",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"exact_snippets": "No unstable angina",
"criterion": "unstable angina",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"exact_snippets": "No clinically significant pericardial effusion or arrhythmia",
"criterion": "clinically significant pericardial effusion or arrhythmia",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"exact_snippets": "Not pregnant or nursing",
"criterion": "pregnancy or nursing",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"exact_snippets": "Adequate contraception required of all fertile patients",
"criterion": "contraception",
"requirement": {
"requirement_type": "requirement",
"expected_value": "adequate contraception"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Age: 18 and over",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "Performance status: ECOG 0-2",
"criterion": "performance status",
"requirement": {
"requirement_type": "scale",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "ECOG"
}
}
},
{
"exact_snippets": "Life expectancy: At least 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Hematopoietic: Absolute granulocyte count at least 1,500/mm3",
"criterion": "absolute granulocyte count",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm3"
}
}
},
{
"exact_snippets": "Platelet count at least 100,000/mm3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm3"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN)",
"criterion": "bilirubin level",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 2.0,
"unit": "mg/dL"
}
}
},
{
"and_criteria": [
{
"exact_snippets": "Cardiovascular: No New York Heart Association Class III or IV heart disease",
"criterion": "New York Heart Association heart disease class",
"requirement": {
"requirement_type": "exclusion",
"expected_value": [
"Class III",
"Class IV"
]
}
},
{
"exact_snippets": "No myocardial infarction within last 6 months",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "recency",
"expected_value": {
"operator": ">",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "No congestive heart failure",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"exact_snippets": "No unstable angina",
"criterion": "unstable angina",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"exact_snippets": "No clinically significant pericardial effusion or arrhythmia",
"criterion": "clinically significant pericardial effusion or arrhythmia",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"exact_snippets": "Not pregnant or nursing",
"criterion": "pregnancy or nursing",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"exact_snippets": "Adequate contraception required of all fertile patients",
"criterion": "contraception",
"requirement": {
"requirement_type": "requirement",
"expected_value": "adequate contraception"
}
}
]
}
},
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
},
{
"exact_snippets": "No concurrent immunotherapy",
"criterion": "concurrent immunotherapy",
"requirement": {
"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",
"requirement": {
"requirement_type": "schedule",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
},
{
"exact_snippets": "No other prior chemotherapy besides platinum and paclitaxel",
"criterion": "prior chemotherapy",
"requirement": {
"requirement_type": "allowed treatments",
"expected_value": [
"platinum",
"paclitaxel"
]
}
},
{
"exact_snippets": "At least 3 weeks since acceptable chemotherapy",
"criterion": "time since acceptable chemotherapy",
"requirement": {
"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",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
},
{
"exact_snippets": "No concurrent hormonal therapy",
"criterion": "concurrent hormonal therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "At least 3 weeks since radiotherapy",
"criterion": "time since radiotherapy",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "At least 3 weeks since immunotherapy",
"criterion": "time since immunotherapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
},
{
"exact_snippets": "No concurrent immunotherapy",
"criterion": "concurrent immunotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Prior paclitaxel treatment must have been administered on a 3 week or greater schedule",
"criterion": "paclitaxel treatment schedule",
"requirement": {
"requirement_type": "schedule",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
},
{
"exact_snippets": "No other prior chemotherapy besides platinum and paclitaxel",
"criterion": "prior chemotherapy",
"requirement": {
"requirement_type": "allowed treatments",
"expected_value": [
"platinum",
"paclitaxel"
]
}
},
{
"exact_snippets": "At least 3 weeks since acceptable chemotherapy",
"criterion": "time since acceptable chemotherapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "At least 3 weeks since hormonal therapy",
"criterion": "time since hormonal therapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
},
{
"exact_snippets": "No concurrent hormonal therapy",
"criterion": "concurrent hormonal therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "At least 3 weeks since radiotherapy",
"criterion": "time since radiotherapy",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
}
]
}
]
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"identified_line": {
"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",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"III",
"IV"
]
}
},
{
"exact_snippets": "Histologically confirmed stage III or IV ovarian cancer",
"criterion": "ovarian cancer",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically"
}
},
{
"exact_snippets": "refractory to an initial chemotherapy regimen that included a platinum agent plus paclitaxel",
"criterion": "chemotherapy regimen",
"requirement": {
"requirement_type": "refractory",
"expected_value": true
}
},
{
"exact_snippets": "refractory to an initial chemotherapy regimen that included a platinum agent plus paclitaxel",
"criterion": "chemotherapy regimen",
"requirement": {
"requirement_type": "components",
"expected_value": [
"platinum agent",
"paclitaxel"
]
}
},
{
"exact_snippets": "Epithelial ovarian cancer",
"criterion": "epithelial ovarian cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Primary carcinoma of the peritoneum",
"criterion": "primary carcinoma of the peritoneum",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Fallopian tube cancer",
"criterion": "fallopian tube cancer",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"requirement_type": "retreatment response",
"expected_value": "refractory"
}
},
{
"exact_snippets": "Measurable or evaluable disease",
"criterion": "disease measurability",
"requirement": {
"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",
"requirement": {
"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",
"requirement": {
"requirement_type": "change",
"expected_value": "doubled from baseline"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
]
}