{
"info": {
"nct_id": "NCT00227773",
"official_title": "Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors",
"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 confirmed low-grade neuroendocrine tumors\n* The following tumor types are excluded:\n* Small cell lung cancer\n* Medullary thyroid cancer\n* Paraganglioma\n* Pheochromocytoma\n* Measurable disease\n* Radiographic evidence of disease progression after completion of any prior systemic therapy, chemoembolization, bland embolization, or observation within the past year, defined as either of the following:\n* Appearance of a new lesion\n* At least 20% increase in the longest diameter (LD) of any previously documented lesion or an increase in the sum of the LDs of multiple lesions in the aggregate of 20%\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,000/mm^3\n* Platelet count ≥ 75,000/mm^3\n* Hemoglobin ≥ 8.0 g/dL\n\nHepatic\n\n* Bilirubin ≤ 2.0 times upper limit of normal (ULN)\n* AST ≤ 3 times ULN (5 times ULN if liver metastases are present)\n\nRenal\n\n* Creatinine ≤ 1.5 times ULN\n* Meets 1 of the following criteria:\n* Urine protein negative by dipstick\n* Urine protein:creatinine ratio < 1.0\n* Urine protein < 1 g by 24-hour urine collection\n\nGastrointestinal\n\n* Must be able to swallow tablets\n* No ulcerative disease\n* No uncontrolled nausea, vomiting, or diarrhea\n* No bowel obstruction\n* No other gastrointestinal tract disease resulting in an inability to take oral medication\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Must be able to receive a contrast-enhanced CT scan\n* No known history of allergic reaction to vatalanib or its derivatives or octreotide injections\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* At least 4 weeks since prior chemotherapy\n* No more than 1 prior systemic chemotherapy regimen\n* Chemoembolization is not considered systemic chemotherapy\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* At least 3 weeks since prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery\n\n* At least 4 weeks since prior major surgery\n\nOther\n\n* At least 4 weeks since other prior systemic therapy\n* At least 4 weeks since prior local liver therapy\n* No prior anti-vascular endothelial growth factor agents\n* No concurrent grapefruit or grapefruit juice\n* No concurrent therapeutic warfarin or similar oral anticoagulants that are metabolized by the cytochrome P450 system\n* Concurrent heparin allowed"
},
"inclusion_lines": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
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"exact_snippets": "Healthy volunteers allowed",
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"expected_value": "healthy"
}
}
]
},
"logical_structure": {
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}
}
]
}
},
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{
"exact_snippets": "minimum age of 18 Years",
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"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
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{
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}
}
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{
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],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "DISEASE CHARACTERISTICS:",
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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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]
}
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{
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}
}
]
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}
}
]
}
},
{
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}
}
]
},
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{
"exact_snippets": "Paraganglioma",
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}
}
]
}
},
{
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}
}
]
},
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{
"exact_snippets": "Pheochromocytoma",
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"expected_value": true
}
}
]
}
},
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"criterion": "disease",
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"expected_value": true
}
}
]
},
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"exact_snippets": "Measurable disease",
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]
}
},
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}
},
{
"exact_snippets": "Radiographic evidence of disease progression after completion of any prior ... chemoembolization",
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"expected_value": "radiographic"
}
},
{
"exact_snippets": "Radiographic evidence of disease progression after completion of any prior ... bland embolization",
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"expected_value": "radiographic"
}
},
{
"exact_snippets": "Radiographic evidence of disease progression after completion of any prior ... observation within the past year",
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}
},
{
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},
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}
]
}
}
}
]
}
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"identified_line": {
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"identified_line": {
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}
}
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}
},
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"identified_line": {
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}
}
]
},
"logical_structure": {
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"exact_snippets": "Renal",
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}
}
]
}
},
{
"identified_line": {
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"identified_line": {
"line": "* No other gastrointestinal tract disease resulting in an inability to take oral medication",
"criterions": [
{
"exact_snippets": "No other gastrointestinal tract disease resulting in an inability to take oral medication",
"criterion": "gastrointestinal tract disease",
"requirement": {
"requirement_type": "resulting in an inability to take oral medication",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No other gastrointestinal tract disease resulting in an inability to take oral medication",
"criterion": "gastrointestinal tract disease",
"requirement": {
"requirement_type": "resulting in an inability to take oral medication",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* No concurrent radiotherapy",
"criterions": [
{
"exact_snippets": "No concurrent radiotherapy",
"criterion": "concurrent radiotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No concurrent radiotherapy",
"criterion": "concurrent radiotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* No prior anti-vascular endothelial growth factor agents",
"criterions": [
{
"exact_snippets": "No prior anti-vascular endothelial growth factor agents",
"criterion": "prior anti-vascular endothelial growth factor agents",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No prior anti-vascular endothelial growth factor agents",
"criterion": "prior anti-vascular endothelial growth factor agents",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
]
}