{
"info": {
"nct_id": "NCT00445848",
"official_title": "A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (RHUMAB VEGF; NSC 704865) in Never-Smokers With Stage IIIB and IV Primary NSCLC Adenocarcinomas",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)\n\n * Adenocarcinoma\n\n * No component of squamous cell carcinoma present\n * Incompletely resected or unresectable disease\n* Stage IIIB or IV disease as defined below:\n\n * Selected stage IIIB disease\n\n * T4 (cytologically confirmed malignant pleural effusion OR pleural tumor foci that are separate from direct pleural invasion by the primary tumor)\n * Any N\n * M0\n * Stage IV disease\n\n * Any T\n * Any N\n * M1 (distant metastases present)\n * Recurrent lung cancer in a separate lobe after resection or radiotherapy within the past 5 years OR multifocal lesions in > 1 lobe considered stage IV disease\n* New lesions occurring ≥ 5 years after resection may be considered a separate primary cancer and are not allowed if this is the only focus of lung cancer\n* Measurable and/or nonmeasurable disease by CT scan, positron emission tomography scan, or MRI\n\n * Disease must be present outside a previous radiotherapy field OR a new lesion must be inside the port\n * Measurable disease must be assessed within the past 28 days\n * Nonmeasurable disease must be assessed within the past 42 days\n * Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease\n* Must be a lifelong nonsmoker (< 100 cigarettes in lifetime)\n* Treated brain metastases allowed provided the patient is asymptomatic and do not require steroids\n\nPATIENT CHARACTERISTICS:\n\n* Zubrod performance status 0-2\n* Absolute neutrophil count ≥ 1,500/mm^3\n* Platelet count ≥ 100,000/mm^3\n* Total bilirubin normal\n* SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)\n* Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases present)\n* Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min\n* Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour urine collection\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Hypertension allowed if controlled on medication prior to study enrollment\n* Must be willing to provide prior smoking history\n* No immediate life-threatening complications from malignancies\n* No prior major medical condition, psychological condition, or social situation that would preclude study treatment\n* No hemoptysis ≥ ½ teaspoon within the past 28 days\n* No clinical history of pulmonary or upper respiratory hemorrhage ≥ grade 2 within the past 6 months or grade 1 within the past 28 days\n* No history of either thrombosis or hemorrhage, including hemorrhagic or thrombotic stroke, or other CNS bleeding\n* No serious nonhealing wound, ulcer, or bone fracture\n* No other prior malignancy except for the following:\n\n * Adequately treated basal cell or squamous cell skin cancer\n * Adequately treated stage I or II cancer from which the patient is currently in complete remission\n * In situ cervical cancer\n * Any other cancer from which the patient has been disease-free for 5 years\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* At least 7 days since prior fine-needle aspiration or core biopsy\n* At least 28 days since prior radiotherapy (14 days for palliative radiotherapy) and recovered\n* At least 28 days since prior surgery (e.g., thoracic or other major surgeries) and recovered\n* At least 28 days since prior systemic chemotherapy\n* Prior biologic therapy allowed\n* No prior gefitinib, erlotinib hydrochloride, bevacizumab, or other targeted therapies against the epidermal growth factor receptor or vascular endothelial growth factor axes\n* Concurrent stable, therapeutic anticoagulation therapy allowed (e.g., warfarin or low molecular weight heparin), provided the patient has no history of bleeding complications on anticoagulation or an inability to establish a stable therapeutic regimen for anticoagulation\n* No concurrent surgery\n* No other concurrent nonprotocol treatment (including chemotherapy, hormonal therapy, biological therapy, or radiotherapy) directed at this cancer"
},
"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 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"
}
}
]
}
]
},
{
"line": "Must have maximum age of 120 Years",
"criterions": [
{
"exact_snippets": "maximum age of 120 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 120,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"line": "DISEASE CHARACTERISTICS:",
"criterions": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)",
"criterions": [
{
"exact_snippets": "Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)",
"criterion": "non-small cell lung cancer (NSCLC)",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": [
"histologically",
"cytologically"
]
}
]
}
]
},
{
"line": "* Adenocarcinoma",
"criterions": [
{
"exact_snippets": "Adenocarcinoma",
"criterion": "adenocarcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No component of squamous cell carcinoma present",
"criterions": [
{
"exact_snippets": "No component of squamous cell carcinoma present",
"criterion": "squamous cell carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Incompletely resected or unresectable disease",
"criterions": [
{
"exact_snippets": "Incompletely resected",
"criterion": "disease resection status",
"requirements": [
{
"requirement_type": "completeness",
"expected_value": "incomplete"
}
]
},
{
"exact_snippets": "unresectable disease",
"criterion": "disease resection status",
"requirements": [
{
"requirement_type": "resectability",
"expected_value": false
}
]
}
]
},
{
"line": "* Stage IIIB or IV disease as defined below:",
"criterions": [
{
"exact_snippets": "Stage IIIB or IV disease",
"criterion": "disease stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"IIIB",
"IV"
]
}
]
}
]
},
{
"line": "* Selected stage IIIB disease",
"criterions": [
{
"exact_snippets": "stage IIIB disease",
"criterion": "disease stage",
"requirements": [
{
"requirement_type": "specific stage",
"expected_value": "IIIB"
}
]
}
]
},
{
"line": "* T4 (cytologically confirmed malignant pleural effusion OR pleural tumor foci that are separate from direct pleural invasion by the primary tumor)",
"criterions": [
{
"exact_snippets": "T4 (cytologically confirmed malignant pleural effusion",
"criterion": "malignant pleural effusion",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "cytologically confirmed"
}
]
},
{
"exact_snippets": "T4 (... OR pleural tumor foci that are separate from direct pleural invasion by the primary tumor)",
"criterion": "pleural tumor foci",
"requirements": [
{
"requirement_type": "separation",
"expected_value": "separate from direct pleural invasion by the primary tumor"
}
]
}
]
},
{
"line": "* Any N",
"criterions": [
{
"exact_snippets": "Any N",
"criterion": "N stage",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* M0",
"criterions": [
{
"exact_snippets": "M0",
"criterion": "distant metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Stage IV disease",
"criterions": [
{
"exact_snippets": "Stage IV disease",
"criterion": "disease stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "IV"
}
]
}
]
},
{
"line": "* Any N",
"criterions": [
{
"exact_snippets": "Any N",
"criterion": "N stage",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* M1 (distant metastases present)",
"criterions": [
{
"exact_snippets": "M1 (distant metastases present)",
"criterion": "distant metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Recurrent lung cancer in a separate lobe after resection or radiotherapy within the past 5 years OR multifocal lesions in > 1 lobe considered stage IV disease",
"criterions": [
{
"exact_snippets": "Recurrent lung cancer in a separate lobe after resection or radiotherapy within the past 5 years",
"criterion": "recurrent lung cancer",
"requirements": [
{
"requirement_type": "location",
"expected_value": "separate lobe"
},
{
"requirement_type": "treatment history",
"expected_value": [
"resection",
"radiotherapy"
]
},
{
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "years"
}
}
]
},
{
"exact_snippets": "multifocal lesions in > 1 lobe considered stage IV disease",
"criterion": "multifocal lesions",
"requirements": [
{
"requirement_type": "location",
"expected_value": "> 1 lobe"
},
{
"requirement_type": "disease stage",
"expected_value": "stage IV"
}
]
}
]
},
{
"line": "* New lesions occurring ≥ 5 years after resection may be considered a separate primary cancer and are not allowed if this is the only focus of lung cancer",
"criterions": [
{
"exact_snippets": "New lesions occurring ≥ 5 years after resection",
"criterion": "new lesions",
"requirements": [
{
"requirement_type": "occurrence time",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "years"
}
}
]
},
{
"exact_snippets": "separate primary cancer",
"criterion": "separate primary cancer",
"requirements": [
{
"requirement_type": "allowance",
"expected_value": false
}
]
},
{
"exact_snippets": "only focus of lung cancer",
"criterion": "focus of lung cancer",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": "only"
}
]
}
]
},
{
"line": "* Measurable and/or nonmeasurable disease by CT scan, positron emission tomography scan, or MRI",
"criterions": [
{
"exact_snippets": "Measurable and/or nonmeasurable disease",
"criterion": "disease measurability",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"measurable",
"nonmeasurable"
]
}
]
},
{
"exact_snippets": "CT scan",
"criterion": "imaging method",
"requirements": [
{
"requirement_type": "method",
"expected_value": "CT scan"
}
]
},
{
"exact_snippets": "positron emission tomography scan",
"criterion": "imaging method",
"requirements": [
{
"requirement_type": "method",
"expected_value": "positron emission tomography scan"
}
]
},
{
"exact_snippets": "MRI",
"criterion": "imaging method",
"requirements": [
{
"requirement_type": "method",
"expected_value": "MRI"
}
]
}
]
},
{
"line": "* Disease must be present outside a previous radiotherapy field OR a new lesion must be inside the port",
"criterions": [
{
"exact_snippets": "Disease must be present outside a previous radiotherapy field",
"criterion": "disease location",
"requirements": [
{
"requirement_type": "location",
"expected_value": "outside previous radiotherapy field"
}
]
},
{
"exact_snippets": "a new lesion must be inside the port",
"criterion": "lesion location",
"requirements": [
{
"requirement_type": "location",
"expected_value": "inside the port"
}
]
}
]
},
{
"line": "* Measurable disease must be assessed within the past 28 days",
"criterions": [
{
"exact_snippets": "Measurable disease must be assessed within the past 28 days",
"criterion": "measurable disease",
"requirements": [
{
"requirement_type": "assessment time frame",
"expected_value": "within the past 28 days"
}
]
}
]
},
{
"line": "* Nonmeasurable disease must be assessed within the past 42 days",
"criterions": [
{
"exact_snippets": "Nonmeasurable disease must be assessed within the past 42 days",
"criterion": "nonmeasurable disease",
"requirements": [
{
"requirement_type": "assessment timeframe",
"expected_value": "within the past 42 days"
}
]
}
]
},
{
"line": "* Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease",
"criterions": [
{
"exact_snippets": "Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease",
"criterion": "pleural effusions",
"requirements": [
{
"requirement_type": "evidence of disease",
"expected_value": false
}
]
},
{
"exact_snippets": "Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease",
"criterion": "ascites",
"requirements": [
{
"requirement_type": "evidence of disease",
"expected_value": false
}
]
},
{
"exact_snippets": "Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease",
"criterion": "laboratory parameters",
"requirements": [
{
"requirement_type": "evidence of disease",
"expected_value": false
}
]
}
]
},
{
"line": "* Must be a lifelong nonsmoker (< 100 cigarettes in lifetime)",
"criterions": [
{
"exact_snippets": "Must be a lifelong nonsmoker (< 100 cigarettes in lifetime)",
"criterion": "smoking history",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 100,
"unit": "cigarettes"
}
}
]
}
]
},
{
"line": "* Treated brain metastases allowed provided the patient is asymptomatic and do not require steroids",
"criterions": [
{
"exact_snippets": "Treated brain metastases allowed",
"criterion": "brain metastases",
"requirements": [
{
"requirement_type": "treatment status",
"expected_value": "treated"
}
]
},
{
"exact_snippets": "provided the patient is asymptomatic",
"criterion": "symptoms",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "do not require steroids",
"criterion": "steroid requirement",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": false
}
]
}
]
},
{
"line": "* Zubrod performance status 0-2",
"criterions": [
{
"exact_snippets": "Zubrod performance status 0-2",
"criterion": "Zubrod performance status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* Absolute neutrophil count ≥ 1,500/mm^3",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count ≥ 1,500/mm^3",
"criterion": "absolute neutrophil count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm^3"
}
}
]
}
]
},
{
"line": "* Platelet count ≥ 100,000/mm^3",
"criterions": [
{
"exact_snippets": "Platelet count ≥ 100,000/mm^3",
"criterion": "platelet count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm^3"
}
}
]
}
]
},
{
"line": "* Total bilirubin normal",
"criterions": [
{
"exact_snippets": "Total bilirubin normal",
"criterion": "total bilirubin",
"requirements": [
{
"requirement_type": "level",
"expected_value": "normal"
}
]
}
]
},
{
"line": "* SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)",
"criterions": [
{
"exact_snippets": "SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)",
"criterion": "SGOT or SGPT levels",
"requirements": [
{
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "times ULN"
}
}
]
},
{
"exact_snippets": "5 times ULN if liver metastases present",
"criterion": "SGOT or SGPT levels with liver metastases",
"requirements": [
{
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "times ULN"
}
}
]
}
]
},
{
"line": "* Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases present)",
"criterions": [
{
"exact_snippets": "Alkaline phosphatase ≤ 2.5 times ULN",
"criterion": "alkaline phosphatase",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "times ULN"
}
}
]
},
{
"exact_snippets": "5 times ULN if bone metastases present",
"criterion": "alkaline phosphatase with bone metastases",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "times ULN"
}
}
]
}
]
},
{
"line": "* Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min",
"criterions": [
{
"exact_snippets": "Creatinine ≤ 1.5 times ULN",
"criterion": "creatinine level",
"requirements": [
{
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times ULN"
}
}
]
},
{
"exact_snippets": "creatinine clearance ≥ 50 mL/min",
"criterion": "creatinine clearance",
"requirements": [
{
"requirement_type": "comparison",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "mL/min"
}
}
]
}
]
},
{
"line": "* Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour urine collection",
"criterions": [
{
"exact_snippets": "Urine protein:creatinine ratio ≤ 0.5",
"criterion": "urine protein:creatinine ratio",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 0.5,
"unit": "N/A"
}
}
]
},
{
"exact_snippets": "urine protein < 1,000 mg by 24-hour urine collection",
"criterion": "urine protein",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 1000,
"unit": "mg"
}
}
]
}
]
},
{
"line": "* Negative pregnancy test",
"criterions": [
{
"exact_snippets": "Negative pregnancy test",
"criterion": "pregnancy test",
"requirements": [
{
"requirement_type": "result",
"expected_value": "negative"
}
]
}
]
},
{
"line": "* Fertile patients must use effective contraception",
"criterions": [
{
"exact_snippets": "Fertile patients",
"criterion": "fertility",
"requirements": [
{
"requirement_type": "status",
"expected_value": "fertile"
}
]
},
{
"exact_snippets": "must use effective contraception",
"criterion": "contraception use",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
}
]
},
{
"line": "* Hypertension allowed if controlled on medication prior to study enrollment",
"criterions": [
{
"exact_snippets": "Hypertension allowed if controlled on medication",
"criterion": "hypertension",
"requirements": [
{
"requirement_type": "control",
"expected_value": "on medication"
}
]
}
]
},
{
"line": "* Must be willing to provide prior smoking history",
"criterions": [
{
"exact_snippets": "Must be willing to provide prior smoking history",
"criterion": "prior smoking history",
"requirements": [
{
"requirement_type": "willingness to provide",
"expected_value": true
}
]
}
]
},
{
"line": "* No immediate life-threatening complications from malignancies",
"criterions": [
{
"exact_snippets": "No immediate life-threatening complications from malignancies",
"criterion": "life-threatening complications from malignancies",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No prior major medical condition, psychological condition, or social situation that would preclude study treatment",
"criterions": [
{
"exact_snippets": "No prior major medical condition",
"criterion": "major medical condition",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No prior ... psychological condition",
"criterion": "psychological condition",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No prior ... social situation that would preclude study treatment",
"criterion": "social situation",
"requirements": [
{
"requirement_type": "impact on study treatment",
"expected_value": false
}
]
}
]
},
{
"line": "* No hemoptysis ≥ ½ teaspoon within the past 28 days",
"criterions": [
{
"exact_snippets": "No hemoptysis ≥ ½ teaspoon within the past 28 days",
"criterion": "hemoptysis",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 0.5,
"unit": "teaspoon"
}
},
{
"requirement_type": "time frame",
"expected_value": "past 28 days"
}
]
}
]
},
{
"line": "* No clinical history of pulmonary or upper respiratory hemorrhage ≥ grade 2 within the past 6 months or grade 1 within the past 28 days",
"criterions": [
{
"exact_snippets": "No clinical history of pulmonary or upper respiratory hemorrhage",
"criterion": "pulmonary or upper respiratory hemorrhage",
"requirements": [
{
"requirement_type": "clinical history",
"expected_value": false
}
]
},
{
"exact_snippets": "≥ grade 2 within the past 6 months",
"criterion": "pulmonary or upper respiratory hemorrhage",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "grade"
}
},
{
"requirement_type": "time frame",
"expected_value": "within the past 6 months"
}
]
},
{
"exact_snippets": "grade 1 within the past 28 days",
"criterion": "pulmonary or upper respiratory hemorrhage",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "=",
"value": 1,
"unit": "grade"
}
},
{
"requirement_type": "time frame",
"expected_value": "within the past 28 days"
}
]
}
]
},
{
"line": "* No history of either thrombosis or hemorrhage, including hemorrhagic or thrombotic stroke, or other CNS bleeding",
"criterions": [
{
"exact_snippets": "No history of either thrombosis",
"criterion": "thrombosis",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
},
{
"exact_snippets": "No history of either ... hemorrhage",
"criterion": "hemorrhage",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
},
{
"exact_snippets": "No history of either ... hemorrhagic ... stroke",
"criterion": "hemorrhagic stroke",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
},
{
"exact_snippets": "No history of either ... thrombotic stroke",
"criterion": "thrombotic stroke",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
},
{
"exact_snippets": "No history of either ... other CNS bleeding",
"criterion": "CNS bleeding",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
}
]
},
{
"line": "* No serious nonhealing wound, ulcer, or bone fracture",
"criterions": [
{
"exact_snippets": "No serious nonhealing wound",
"criterion": "nonhealing wound",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "not serious"
}
]
},
{
"exact_snippets": "No serious nonhealing ... ulcer",
"criterion": "ulcer",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "not serious"
},
{
"requirement_type": "healing status",
"expected_value": "healing"
}
]
},
{
"exact_snippets": "No serious nonhealing ... bone fracture",
"criterion": "bone fracture",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "not serious"
},
{
"requirement_type": "healing status",
"expected_value": "healing"
}
]
}
]
},
{
"line": "* No other prior malignancy except for the following:",
"criterions": [
{
"exact_snippets": "No other prior malignancy",
"criterion": "prior malignancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Adequately treated basal cell or squamous cell skin cancer",
"criterions": [
{
"exact_snippets": "Adequately treated basal cell ... skin cancer",
"criterion": "basal cell skin cancer",
"requirements": [
{
"requirement_type": "treatment status",
"expected_value": "adequately treated"
}
]
},
{
"exact_snippets": "Adequately treated ... squamous cell skin cancer",
"criterion": "squamous cell skin cancer",
"requirements": [
{
"requirement_type": "treatment status",
"expected_value": "adequately treated"
}
]
}
]
},
{
"line": "* Adequately treated stage I or II cancer from which the patient is currently in complete remission",
"criterions": [
{
"exact_snippets": "Adequately treated stage I or II cancer",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"I",
"II"
]
},
{
"requirement_type": "treatment status",
"expected_value": "adequately treated"
}
]
},
{
"exact_snippets": "patient is currently in complete remission",
"criterion": "remission status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "complete remission"
}
]
}
]
},
{
"line": "* In situ cervical cancer",
"criterions": [
{
"exact_snippets": "In situ cervical cancer",
"criterion": "cervical cancer",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "in situ"
}
]
}
]
},
{
"line": "* Any other cancer from which the patient has been disease-free for 5 years",
"criterions": [
{
"exact_snippets": "Any other cancer from which the patient has been disease-free for 5 years",
"criterion": "other cancer",
"requirements": [
{
"requirement_type": "disease-free duration",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "years"
}
}
]
}
]
},
{
"line": "PRIOR CONCURRENT THERAPY:",
"criterions": [
{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
"criterion": "prior concurrent 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 details"
}
]
}
]
},
{
"line": "* At least 7 days since prior fine-needle aspiration or core biopsy",
"criterions": [
{
"exact_snippets": "At least 7 days since prior fine-needle aspiration",
"criterion": "time since fine-needle aspiration",
"requirements": [
{
"requirement_type": "time since procedure",
"expected_value": {
"operator": ">=",
"value": 7,
"unit": "days"
}
}
]
},
{
"exact_snippets": "At least 7 days since prior ... core biopsy",
"criterion": "time since core biopsy",
"requirements": [
{
"requirement_type": "time since procedure",
"expected_value": {
"operator": ">=",
"value": 7,
"unit": "days"
}
}
]
}
]
},
{
"line": "* At least 28 days since prior radiotherapy (14 days for palliative radiotherapy) and recovered",
"criterions": [
{
"exact_snippets": "At least 28 days since prior radiotherapy",
"criterion": "time since prior radiotherapy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 28,
"unit": "days"
}
}
]
},
{
"exact_snippets": "14 days for palliative radiotherapy",
"criterion": "time since prior palliative radiotherapy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 14,
"unit": "days"
}
}
]
},
{
"exact_snippets": "recovered",
"criterion": "recovery from radiotherapy",
"requirements": [
{
"requirement_type": "status",
"expected_value": "recovered"
}
]
}
]
},
{
"line": "* At least 28 days since prior surgery (e.g., thoracic or other major surgeries) and recovered",
"criterions": [
{
"exact_snippets": "At least 28 days since prior surgery",
"criterion": "time since prior surgery",
"requirements": [
{
"requirement_type": "time since",
"expected_value": {
"operator": ">=",
"value": 28,
"unit": "days"
}
}
]
},
{
"exact_snippets": "recovered",
"criterion": "recovery from prior surgery",
"requirements": [
{
"requirement_type": "recovery status",
"expected_value": true
}
]
}
]
},
{
"line": "* At least 28 days since prior systemic chemotherapy",
"criterions": [
{
"exact_snippets": "At least 28 days since prior systemic chemotherapy",
"criterion": "time since prior systemic chemotherapy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 28,
"unit": "days"
}
}
]
}
]
},
{
"line": "* Prior biologic therapy allowed",
"criterions": [
{
"exact_snippets": "Prior biologic therapy allowed",
"criterion": "biologic therapy",
"requirements": [
{
"requirement_type": "prior treatment",
"expected_value": true
}
]
}
]
},
{
"line": "* No prior gefitinib, erlotinib hydrochloride, bevacizumab, or other targeted therapies against the epidermal growth factor receptor or vascular endothelial growth factor axes",
"criterions": [
{
"exact_snippets": "No prior gefitinib",
"criterion": "prior gefitinib",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No prior ... erlotinib hydrochloride",
"criterion": "prior erlotinib hydrochloride",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No prior ... bevacizumab",
"criterion": "prior bevacizumab",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No prior ... other targeted therapies against the epidermal growth factor receptor",
"criterion": "prior targeted therapies against the epidermal growth factor receptor",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No prior ... other targeted therapies against the ... vascular endothelial growth factor axes",
"criterion": "prior targeted therapies against the vascular endothelial growth factor axes",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Concurrent stable, therapeutic anticoagulation therapy allowed (e.g., warfarin or low molecular weight heparin), provided the patient has no history of bleeding complications on anticoagulation or an inability to establish a stable therapeutic regimen for anticoagulation",
"criterions": [
{
"exact_snippets": "Concurrent stable, therapeutic anticoagulation therapy allowed",
"criterion": "anticoagulation therapy",
"requirements": [
{
"requirement_type": "stability",
"expected_value": "stable"
},
{
"requirement_type": "therapeutic",
"expected_value": true
}
]
},
{
"exact_snippets": "provided the patient has no history of bleeding complications on anticoagulation",
"criterion": "history of bleeding complications on anticoagulation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "provided the patient has no ... inability to establish a stable therapeutic regimen for anticoagulation",
"criterion": "ability to establish a stable therapeutic regimen for anticoagulation",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* No concurrent surgery",
"criterions": [
{
"exact_snippets": "No concurrent surgery",
"criterion": "concurrent surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No other concurrent nonprotocol treatment (including chemotherapy, hormonal therapy, biological therapy, or radiotherapy) directed at this cancer",
"criterions": [
{
"exact_snippets": "No other concurrent nonprotocol treatment (including chemotherapy, hormonal therapy, biological therapy, or radiotherapy)",
"criterion": "concurrent nonprotocol treatment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "directed at this cancer",
"criterion": "treatment target",
"requirements": [
{
"requirement_type": "target",
"expected_value": "this cancer"
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"line": "* Any T",
"criterions": []
},
{
"line": "PATIENT CHARACTERISTICS:",
"criterions": []
},
{
"line": "* Not pregnant or nursing",
"criterions": [
{
"exact_snippets": "Not pregnant",
"criterion": "pregnancy status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "not pregnant"
}
]
},
{
"exact_snippets": "not ... nursing",
"criterion": "nursing status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "not nursing"
}
]
}
]
}
]
}