{
"info": {
"nct_id": "NCT00101348",
"official_title": "A Phase I, and Biologic Correlative Study of Erlotinib, in Combination With Cetuximab and Bevacizumab in Patients With Metastatic Renal Cell Carcinoma",
"inclusion_criteria": "* One of the following histologically confirmed diagnoses:\n\n * Renal cell cancer\n\n * Clear cell histology\n * Metastatic or unresectable disease AND meets 1 of the following criteria:\n\n * Recurrent disease\n * Refractory to interleukin-2 (IL-2)- or interferon-based therapy\n * Previously untreated AND not a candidate for IL-2-based therapy\n * Colorectal, head and neck, pancreatic, or non-small cell lung cancer\n\n * Metastatic or unresectable disease\n * Progression after prior standard treatment\n* No evidence of CNS disease, including the following (part 2 only):\n\n * Primary brain tumor\n * Brain metastases\n* Paraffin embedded tumor blocks available\n* Performance status - ECOG 0-2\n* Performance status - Karnofsky 60-100%\n* More than 12 weeks\n* Absolute neutrophil count ≥ 1,500 mm^3\n* Platelet count ≥ 100,000 mm^3\n* Bilirubin ≤ 1.5 mg/dL\n* AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastasis is present)\n* PTT and INR ≤ 1.5, unless receiving full-dose warfarin (part 2 only)\n* Creatinine ≤ 1.5 times ULN\n* Creatinine clearance ≥ 60 mL/min\n* Calcium < 10 mg/dL (hypocalcemic agents allowed)\n* No proteinuria*\n* Protein < 1 g on 24-hour urine collection*\n* No unstable angina pectoris\n* No cardiac arrhythmia\n* No symptomatic congestive heart failure\n* None of the following are allowed for part 2:\n\n * Myocardial infarction within the past 6 months\n * New York Heart Association class II-IV heart disease\n * Serious cardiac arrhythmia requiring medication\n * Peripheral vascular disease ≥ grade II\n * Recent history of cerebrovascular accident\n * Uncontrolled hypertension (blood pressure ≥ 150/85 mm Hg despite medication)\n * Other clinically significant cardiovascular disease\n* No gastrointestinal (GI) tract disease resulting in an inability to take oral medication\n* No GI tract disease resulting in a requirement for IV alimentation\n* No active peptic ulcer disease\n* No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs\n* No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies (part 2 only)\n* No ongoing or active infection\n* No active infection requiring parenteral antibiotics (part 2 only)\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 2 months after study treatment\n* No significant traumatic injury within the past 28 days (part 2 only)\n* No history of abnormalities of the cornea (e.g., dry eye syndrome, Sjögren's syndrome, or congenital abnormality [e.g., Fuch's dystrophy])\n* No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the breast or cervix\n* No psychiatric illness or social situation that would preclude study compliance\n* No serious or non-healing wound ulcer or bone fracture (part 2 only)\n* No other uncontrolled illness\n* See Disease Characteristics\n* More than 4 weeks since prior immunotherapy\n* No prior cetuximab\n* No prior bevacizumab\n* Concurrent epoetin alfa or darbepoetin alfa allowed\n* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)\n* More than 4 weeks since prior radiotherapy\n* No prior surgical procedures affecting absorption\n* Prior nephrectomy or resection of metastatic lesions allowed provided patient has fully recovered\n* More than 7 days since prior core biopsy*\n* More than 28 days since prior major surgery or open biopsy*\n* No concurrent major surgery*\n* Recovered from all prior therapy\n* No prior erlotinib\n* Concurrent bisphosphonates allowed\n* Concurrent full-dose anticoagulants allowed provided the following criteria are met (part 2 only):\n\n * In-range INR (usually between 2 and 3) AND on a stable dose of warfarin or low molecular weight heparin\n * No active bleeding\n * No pathological conditions that carry a high risk of bleeding (e.g., tumor involving major vessels or varices)\n* No other concurrent investigational agents\n* No concurrent combination antiretroviral therapy for HIV-positive patients\n* No other concurrent anticancer therapy\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* One of the following histologically confirmed diagnoses:",
"criterions": [
{
"exact_snippets": "One of the following histologically confirmed diagnoses",
"criterion": "histologically confirmed diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "One of the following histologically confirmed diagnoses",
"criterion": "histologically confirmed diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Renal cell cancer",
"criterions": [
{
"exact_snippets": "Renal cell cancer",
"criterion": "renal cell cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Renal cell cancer",
"criterion": "renal cell cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Clear cell histology",
"criterions": [
{
"exact_snippets": "Clear cell histology",
"criterion": "histology",
"requirement": {
"requirement_type": "type",
"expected_value": "clear cell"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Clear cell histology",
"criterion": "histology",
"requirement": {
"requirement_type": "type",
"expected_value": "clear cell"
}
}
]
}
},
{
"identified_line": {
"line": "* Metastatic or unresectable disease AND meets 1 of the following criteria:",
"criterions": [
{
"exact_snippets": "Metastatic or unresectable disease",
"criterion": "disease status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"metastatic",
"unresectable"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Metastatic or unresectable disease",
"criterion": "disease status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"metastatic",
"unresectable"
]
}
},
{
"or_criteria": [
{
"exact_snippets": "meets 1 of the following criteria",
"criterion": "additional criteria",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Recurrent disease",
"criterions": [
{
"exact_snippets": "Recurrent disease",
"criterion": "disease recurrence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Recurrent disease",
"criterion": "disease recurrence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Previously untreated AND not a candidate for IL-2-based therapy",
"criterions": [
{
"exact_snippets": "Previously untreated",
"criterion": "treatment history",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "untreated"
}
},
{
"exact_snippets": "not a candidate for IL-2-based therapy",
"criterion": "IL-2-based therapy candidacy",
"requirement": {
"requirement_type": "candidacy",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Previously untreated",
"criterion": "treatment history",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "untreated"
}
},
{
"exact_snippets": "not a candidate for IL-2-based therapy",
"criterion": "IL-2-based therapy candidacy",
"requirement": {
"requirement_type": "candidacy",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Colorectal, head and neck, pancreatic, or non-small cell lung cancer",
"criterions": [
{
"exact_snippets": "Colorectal",
"criterion": "cancer type",
"requirement": {
"requirement_type": "presence",
"expected_value": "colorectal"
}
},
{
"exact_snippets": "head and neck",
"criterion": "cancer type",
"requirement": {
"requirement_type": "presence",
"expected_value": "head and neck"
}
},
{
"exact_snippets": "pancreatic",
"criterion": "cancer type",
"requirement": {
"requirement_type": "presence",
"expected_value": "pancreatic"
}
},
{
"exact_snippets": "non-small cell lung",
"criterion": "cancer type",
"requirement": {
"requirement_type": "presence",
"expected_value": "non-small cell lung"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Colorectal",
"criterion": "cancer type",
"requirement": {
"requirement_type": "presence",
"expected_value": "colorectal"
}
},
{
"exact_snippets": "head and neck",
"criterion": "cancer type",
"requirement": {
"requirement_type": "presence",
"expected_value": "head and neck"
}
},
{
"exact_snippets": "pancreatic",
"criterion": "cancer type",
"requirement": {
"requirement_type": "presence",
"expected_value": "pancreatic"
}
},
{
"exact_snippets": "non-small cell lung",
"criterion": "cancer type",
"requirement": {
"requirement_type": "presence",
"expected_value": "non-small cell lung"
}
}
]
}
},
{
"identified_line": {
"line": "* Metastatic or unresectable disease",
"criterions": [
{
"exact_snippets": "Metastatic",
"criterion": "disease state",
"requirement": {
"requirement_type": "presence",
"expected_value": "metastatic"
}
},
{
"exact_snippets": "unresectable disease",
"criterion": "disease state",
"requirement": {
"requirement_type": "resectability",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Metastatic",
"criterion": "disease state",
"requirement": {
"requirement_type": "presence",
"expected_value": "metastatic"
}
},
{
"exact_snippets": "unresectable disease",
"criterion": "disease state",
"requirement": {
"requirement_type": "resectability",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Progression after prior standard treatment",
"criterions": [
{
"exact_snippets": "Progression after prior standard treatment",
"criterion": "progression",
"requirement": {
"requirement_type": "after prior standard treatment",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Progression after prior standard treatment",
"criterion": "progression",
"requirement": {
"requirement_type": "after prior standard treatment",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* No evidence of CNS disease, including the following (part 2 only):",
"criterions": [
{
"exact_snippets": "No evidence of CNS disease",
"criterion": "CNS disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No evidence of CNS disease",
"criterion": "CNS disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Primary brain tumor",
"criterions": [
{
"exact_snippets": "Primary brain tumor",
"criterion": "primary brain tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Primary brain tumor",
"criterion": "primary brain tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Brain metastases",
"criterions": [
{
"exact_snippets": "Brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Paraffin embedded tumor blocks available",
"criterions": [
{
"exact_snippets": "Paraffin embedded tumor blocks available",
"criterion": "paraffin embedded tumor blocks",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Paraffin embedded tumor blocks available",
"criterion": "paraffin embedded tumor blocks",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Performance status - ECOG 0-2",
"criterions": [
{
"exact_snippets": "Performance status - ECOG 0-2",
"criterion": "performance status",
"requirement": {
"requirement_type": "scale",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "ECOG"
},
{
"operator": "<=",
"value": 2,
"unit": "ECOG"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Performance status - ECOG 0-2",
"criterion": "performance status",
"requirement": {
"requirement_type": "scale",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "ECOG"
},
{
"operator": "<=",
"value": 2,
"unit": "ECOG"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Performance status - Karnofsky 60-100%",
"criterions": [
{
"exact_snippets": "Performance status - Karnofsky 60-100%",
"criterion": "performance status",
"requirement": {
"requirement_type": "Karnofsky score",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 60,
"unit": "%"
},
{
"operator": "<=",
"value": 100,
"unit": "%"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Performance status - Karnofsky 60-100%",
"criterion": "performance status",
"requirement": {
"requirement_type": "Karnofsky score",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 60,
"unit": "%"
},
{
"operator": "<=",
"value": 100,
"unit": "%"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* More than 12 weeks",
"criterions": [
{
"exact_snippets": "More than 12 weeks",
"criterion": "duration",
"requirement": {
"requirement_type": "length",
"expected_value": {
"operator": ">",
"value": 12,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "More than 12 weeks",
"criterion": "duration",
"requirement": {
"requirement_type": "length",
"expected_value": {
"operator": ">",
"value": 12,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Absolute neutrophil count ≥ 1,500 mm^3",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count ≥ 1,500 mm^3",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm^3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Absolute neutrophil count ≥ 1,500 mm^3",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm^3"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Platelet count ≥ 100,000 mm^3",
"criterions": [
{
"exact_snippets": "Platelet count ≥ 100,000 mm^3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm^3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Platelet count ≥ 100,000 mm^3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm^3"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Bilirubin ≤ 1.5 mg/dL",
"criterions": [
{
"exact_snippets": "Bilirubin ≤ 1.5 mg/dL",
"criterion": "bilirubin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "mg/dL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Bilirubin ≤ 1.5 mg/dL",
"criterion": "bilirubin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "mg/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastasis is present)",
"criterions": [
{
"exact_snippets": "AST and ALT ≤ 2.5 times upper limit of normal (ULN)",
"criterion": "AST and ALT levels",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "times ULN"
}
}
},
{
"exact_snippets": "AST and ALT ... (5 times ULN if liver metastasis is present)",
"criterion": "AST and ALT levels with liver metastasis",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "times ULN"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "liver metastasis",
"criterion": "liver metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "AST and ALT ... (5 times ULN if liver metastasis is present)",
"criterion": "AST and ALT levels with liver metastasis",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "times ULN"
}
}
},
"else_criteria": {
"exact_snippets": "AST and ALT ≤ 2.5 times upper limit of normal (ULN)",
"criterion": "AST and ALT levels",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "times ULN"
}
}
}
}
},
{
"identified_line": {
"line": "* Creatinine ≤ 1.5 times ULN",
"criterions": [
{
"exact_snippets": "Creatinine ≤ 1.5 times ULN",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Creatinine ≤ 1.5 times ULN",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Creatinine clearance ≥ 60 mL/min",
"criterions": [
{
"exact_snippets": "Creatinine clearance ≥ 60 mL/min",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "mL/min"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Creatinine clearance ≥ 60 mL/min",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "mL/min"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Calcium < 10 mg/dL (hypocalcemic agents allowed)",
"criterions": [
{
"exact_snippets": "Calcium < 10 mg/dL",
"criterion": "calcium level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 10,
"unit": "mg/dL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Calcium < 10 mg/dL",
"criterion": "calcium level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 10,
"unit": "mg/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* No proteinuria*",
"criterions": [
{
"exact_snippets": "No proteinuria",
"criterion": "proteinuria",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No proteinuria",
"criterion": "proteinuria",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Protein < 1 g on 24-hour urine collection*",
"criterions": [
{
"exact_snippets": "Protein < 1 g on 24-hour urine collection",
"criterion": "protein in urine",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 1,
"unit": "g"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Protein < 1 g on 24-hour urine collection",
"criterion": "protein in urine",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 1,
"unit": "g"
}
}
}
]
}
},
{
"identified_line": {
"line": "* No unstable angina pectoris",
"criterions": [
{
"exact_snippets": "No unstable angina pectoris",
"criterion": "unstable angina pectoris",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No unstable angina pectoris",
"criterion": "unstable angina pectoris",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* No cardiac arrhythmia",
"criterions": [
{
"exact_snippets": "No cardiac arrhythmia",
"criterion": "cardiac arrhythmia",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "No cardiac arrhythmia",
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}
}
]
}
},
{
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"line": "* No symptomatic congestive heart failure",
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{
"exact_snippets": "No symptomatic congestive heart failure",
"criterion": "symptomatic congestive heart failure",
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}
}
]
},
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}
}
}
},
{
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"line": "* None of the following are allowed for part 2:",
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{
"exact_snippets": "None of the following are allowed for part 2",
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}
}
]
},
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}
}
}
},
{
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"line": "* Myocardial infarction within the past 6 months",
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{
"exact_snippets": "Myocardial infarction within the past 6 months",
"criterion": "myocardial infarction",
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"requirement_type": "time since event",
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"operator": "<=",
"value": 6,
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}
}
]
},
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"operator": "<=",
"value": 6,
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}
}
]
}
},
{
"identified_line": {
"line": "* New York Heart Association class II-IV heart disease",
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{
"exact_snippets": "New York Heart Association class II-IV heart disease",
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{
"operator": ">=",
"value": 2,
"unit": "class"
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{
"operator": "<=",
"value": 4,
"unit": "class"
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]
}
}
}
]
},
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{
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{
"operator": ">=",
"value": 2,
"unit": "class"
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{
"operator": "<=",
"value": 4,
"unit": "class"
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}
}
}
]
}
},
{
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},
{
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}
]
},
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},
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}
]
}
},
{
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"line": "* Peripheral vascular disease ≥ grade II",
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{
"exact_snippets": "Peripheral vascular disease ≥ grade II",
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"operator": ">=",
"value": 2,
"unit": "grade"
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}
}
]
},
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{
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"operator": ">=",
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}
}
]
}
},
{
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"line": "* Recent history of cerebrovascular accident",
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"requirement_type": "history",
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}
]
},
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{
"exact_snippets": "Recent history of cerebrovascular accident",
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"requirement_type": "history",
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}
]
}
},
{
"identified_line": {
"line": "* Uncontrolled hypertension (blood pressure ≥ 150/85 mm Hg despite medication)",
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{
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},
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"operator": ">=",
"value": 150,
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}
},
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"requirement_type": "measurement",
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"operator": ">=",
"value": 85,
"unit": "mm Hg"
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}
}
]
},
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"and_criteria": [
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"exact_snippets": "Uncontrolled hypertension",
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},
{
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}
},
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}
}
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}
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}
]
}
},
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"line": "* Other clinically significant cardiovascular disease",
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]
},
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}
]
}
},
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"identified_line": {
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}
]
},
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}
]
}
},
{
"identified_line": {
"line": "* No GI tract disease resulting in a requirement for IV alimentation",
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},
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},
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]
}
},
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"line": "* No active peptic ulcer disease",
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"exact_snippets": "No active peptic ulcer disease",
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"requirement_type": "presence",
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}
},
{
"exact_snippets": "No active peptic ulcer disease",
"criterion": "peptic ulcer disease",
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"requirement_type": "activity",
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}
]
},
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"exact_snippets": "No active peptic ulcer disease",
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"expected_value": false
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"requirement_type": "activity",
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}
]
}
},
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"requirement_type": "presence",
"expected_value": false
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}
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"requirement_type": "presence",
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}
]
}
},
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"line": "* No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies (part 2 only)",
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"requirement_type": "presence",
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}
},
{
"exact_snippets": "No known hypersensitivity to ... other recombinant human antibodies",
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"requirement_type": "presence",
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]
},
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},
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}
]
}
},
{
"identified_line": {
"line": "* No ongoing or active infection",
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}
]
},
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]
}
},
{
"identified_line": {
"line": "* No active infection requiring parenteral antibiotics (part 2 only)",
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{
"exact_snippets": "No active infection",
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"requirement_type": "presence",
"expected_value": false
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},
{
"exact_snippets": "requiring parenteral antibiotics",
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}
]
}
},
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"identified_line": {
"line": "* Negative pregnancy test",
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"exact_snippets": "Negative pregnancy test",
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"requirement_type": "result",
"expected_value": "negative"
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}
]
},
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"exact_snippets": "Negative pregnancy test",
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]
}
},
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"identified_line": {
"line": "* Fertile patients must use effective contraception during and for 2 months after study treatment",
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{
"exact_snippets": "Fertile patients",
"criterion": "fertility",
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"requirement_type": "status",
"expected_value": "fertile"
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},
{
"exact_snippets": "must use effective contraception",
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},
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"exact_snippets": "during and for 2 months after study treatment",
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},
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},
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},
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]
},
"else_criteria": null
}
},
{
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"operator": "<",
"value": 28,
"unit": "days"
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}
}
]
},
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}
}
]
}
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}
},
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"exact_snippets": "No history of abnormalities of the cornea",
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},
{
"exact_snippets": "dry eye syndrome",
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"requirement_type": "history",
"expected_value": false
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},
{
"exact_snippets": "Sjögren's syndrome",
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},
{
"exact_snippets": "congenital abnormality",
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},
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]
},
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}
},
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},
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},
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]
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},
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"exact_snippets": "No ... social situation that would preclude study compliance",
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]
}
},
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},
"then_criteria": null,
"else_criteria": {
"exact_snippets": "unless receiving full-dose warfarin (part 2 only)",
"criterion": "warfarin treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* No prior erlotinib",
"criterions": [
{
"exact_snippets": "No prior erlotinib",
"criterion": "prior erlotinib",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No prior erlotinib",
"criterion": "prior erlotinib",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}