{
"info": {
"nct_id": "NCT00690872",
"official_title": "Phase II Trial Evaluating Efficacy of a Strategy Employing Combination Gemcitabine and Carboplatin Chemotherapy Followed by EBV-Specific Cytotoxic T-Lymphocytes in Patients With Metastatic or Locally Recurrent EBV-Positive Nasopharyngeal Carcinoma",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 21 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Biopsy-proven nasopharyngeal carcinoma (NPC)\n\n * WHO type 2/3 disease\n * Metastatic or locally recurrent disease\n* Epstein-Barr virus (EBV)-positive disease as confirmed by in situ hybridization assay or PCR amplification for EBV-encoded RNA expression\n* Radiologically measurable disease\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Life expectancy > 3 months\n* ANC > 1,200/mm^3\n* Platelet count ≥ 100,000/mm^3\n* Hemoglobin ≥ 8 g/dL\n* Bilirubin < 2 times upper limit of normal (ULN)\n* AST and ALT < 3 times ULN\n* Creatinine clearance ≥ 40 mL/min\n* Corrected calcium normal\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No concurrent severe illness, including any of the following:\n\n * Chronic obstructive pulmonary disease\n * Ischemic heart disease\n * Active congestive cardiac failure\n * Active angina pectoris\n * Uncontrolled arrhythmia\n * Uncontrolled hypertension\n* No concurrent severe infections\n* HIV negative\n\nPRIOR CONCURRENT THERAPY:\n\n* No more than one line of prior chemotherapy for metastatic disease\n* No prior gemcitabine hydrochloride\n* Prior platinum agents allowed\n* At least 1 month since prior investigational therapy"
},
"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": {
"and_criteria": [
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "minimum age of 21 Years",
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"expected_value": {
"operator": ">=",
"value": 21,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 21 Years",
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"value": 21,
"unit": "Years"
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}
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}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "DISEASE CHARACTERISTICS:",
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"exact_snippets": "DISEASE CHARACTERISTICS",
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"requirement": {
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"expected_value": true
}
}
]
},
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"exact_snippets": "DISEASE CHARACTERISTICS",
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}
]
}
},
{
"identified_line": {
"line": "* Biopsy-proven nasopharyngeal carcinoma (NPC)",
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{
"exact_snippets": "Biopsy-proven nasopharyngeal carcinoma (NPC)",
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}
}
]
},
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"exact_snippets": "Biopsy-proven nasopharyngeal carcinoma (NPC)",
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}
]
}
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{
"identified_line": {
"line": "* WHO type 2/3 disease",
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}
},
{
"exact_snippets": "locally recurrent disease",
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},
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"identified_line": {
"line": "* Epstein-Barr virus (EBV)-positive disease as confirmed by in situ hybridization assay or PCR amplification for EBV-encoded RNA expression",
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{
"exact_snippets": "Epstein-Barr virus (EBV)-positive disease",
"criterion": "Epstein-Barr virus (EBV) status",
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"expected_value": "positive"
}
},
{
"exact_snippets": "confirmed by in situ hybridization assay",
"criterion": "confirmation method",
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}
},
{
"exact_snippets": "confirmed by ... PCR amplification for EBV-encoded RNA expression",
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}
}
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"and_criteria": [
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"and_criteria": [
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"exact_snippets": "Epstein-Barr virus (EBV)-positive disease",
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{
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},
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"exact_snippets": "confirmed by ... PCR amplification for EBV-encoded RNA expression",
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}
]
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}
},
{
"identified_line": {
"line": "* Radiologically measurable disease",
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"exact_snippets": "Radiologically measurable disease",
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"expected_value": "radiologically measurable"
}
}
]
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"exact_snippets": "Radiologically measurable disease",
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}
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]
}
},
{
"identified_line": {
"line": "* ECOG performance status 0-2",
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{
"exact_snippets": "ECOG performance status 0-2",
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"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
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"exact_snippets": "ECOG performance status 0-2",
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"operator": ">=",
"value": 0,
"unit": "N/A"
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{
"operator": "<=",
"value": 2,
"unit": "N/A"
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]
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}
}
]
}
},
{
"identified_line": {
"line": "* Life expectancy > 3 months",
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{
"exact_snippets": "Life expectancy > 3 months",
"criterion": "life expectancy",
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"operator": ">",
"value": 3,
"unit": "months"
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}
}
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"exact_snippets": "Life expectancy > 3 months",
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"operator": ">",
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"unit": "months"
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]
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},
{
"identified_line": {
"line": "* ANC > 1,200/mm^3",
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"exact_snippets": "ANC > 1,200/mm^3",
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"operator": ">",
"value": 1200,
"unit": "mm^3"
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{
"identified_line": {
"line": "* Platelet count ≥ 100,000/mm^3",
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"exact_snippets": "Platelet count ≥ 100,000/mm^3",
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"operator": ">=",
"value": 100000,
"unit": "mm^3"
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"exact_snippets": "Active angina pectoris",
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}
}
]
},
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"criterion": "arrhythmia",
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}
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"exact_snippets": "PRIOR CONCURRENT THERAPY",
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"exact_snippets": "PRIOR CONCURRENT THERAPY",
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]
}
},
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"line": "* Not pregnant or nursing",
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],
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"failed_exclusion": [],
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{
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"line": "* Creatinine clearance ≥ 40 mL/min",
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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": "Fertile patients",
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"expected_value": "fertile"
}
},
{
"exact_snippets": "must use effective contraception",
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"expected_value": true
}
},
{
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}
}
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},
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{
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}
}
]
},
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}
}
},
{
"identified_line": {
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"criterions": [
{
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"expected_value": false
}
}
]
},
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}
}
}
},
{
"identified_line": {
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"criterions": [
{
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}
}
]
},
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}
}
}
}
]
}