{
"info": {
"nct_id": "NCT00361231",
"official_title": "Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Unresectable or Metastatic Biliary Tract and Gallbladder Cancer",
"inclusion_criteria": "* Histologically confirmed, locally unresectable or metastatic biliary tract or gallbladder adenocarcinoma. Patients must have at least one measurable lesion outside prior radiation field.\n* Zero to one prior chemotherapy for biliary tract or gallbladder cancer\n* Age > 18 years\n* ECOG performance status 0-2\n* Life expectancy > 12 weeks\n* Adequate organ and bone marrow function\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Chemotherapy within past 3 weeks of initiation of therapy\n* Pregnant or lactating women\n* Clinically apparent central nervous system metastases or carcinomatous meningitis\n* Biliary obstruction with inadequate drainage and total bilirubin > 2.5 mg/dL\n* Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\n* Uncontrolled serious medical or psychiatric illness\n* Pre-existing peripheral neuropathy of grade 2 or greater severity according to the Common Terminology Criteria of the NCI (version 3.0)\n* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study\n* Blood pressure of > 150/100 mmHg\n* Unstable angina\n* NYHA Grade II or greater congestive heart failure\n* History of myocardial infarction or stroke within 6 months\n* Clinically significant peripheral vascular disease\n* Evidence of bleeding diathesis or coagulopathy\n* Major surgical procedure, open biopsy, or significant traumatic injury with 28 days prior to Day 1, anticipation of need for major surgical procedure during the course of the study\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1\n* Serious, non-healing wound, ulcer, or bone fracture",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Histologically confirmed, locally unresectable or metastatic biliary tract or gallbladder adenocarcinoma. Patients must have at least one measurable lesion outside prior radiation field.",
"criterions": [
{
"exact_snippets": "Histologically confirmed, locally unresectable or metastatic biliary tract or gallbladder adenocarcinoma",
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"requirement": {
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"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "Histologically confirmed, locally unresectable or metastatic biliary tract or gallbladder adenocarcinoma",
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"requirement": {
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"expected_value": "locally unresectable"
}
},
{
"exact_snippets": "Histologically confirmed, locally unresectable or metastatic biliary tract or gallbladder adenocarcinoma",
"criterion": "biliary tract or gallbladder adenocarcinoma",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Patients must have at least one measurable lesion outside prior radiation field",
"criterion": "measurable lesion",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesion"
}
}
},
{
"exact_snippets": "Patients must have at least one measurable lesion outside prior radiation field",
"criterion": "measurable lesion",
"requirement": {
"requirement_type": "location",
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}
}
]
},
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"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Histologically confirmed, locally unresectable or metastatic biliary tract or gallbladder adenocarcinoma",
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{
"exact_snippets": "Histologically confirmed, locally unresectable or metastatic biliary tract or gallbladder adenocarcinoma",
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{
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"and_criteria": [
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"value": 1,
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}
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]
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"identified_line": {
"line": "* Age > 18 years",
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{
"exact_snippets": "Age > 18 years",
"criterion": "age",
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"operator": ">",
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"unit": "years"
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"and_criteria": [
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"exact_snippets": "Age > 18 years",
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"operator": ">",
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"identified_line": {
"line": "* ECOG performance status 0-2",
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{
"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"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
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}
},
{
"identified_line": {
"line": "* Life expectancy > 12 weeks",
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{
"exact_snippets": "Life expectancy > 12 weeks",
"criterion": "life expectancy",
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"operator": ">",
"value": 12,
"unit": "weeks"
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"exact_snippets": "Life expectancy > 12 weeks",
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"operator": ">",
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"unit": "weeks"
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"identified_line": {
"line": "* Adequate organ and bone marrow function",
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{
"exact_snippets": "Adequate organ ... function",
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"expected_value": true
}
},
{
"exact_snippets": "Adequate ... bone marrow function",
"criterion": "bone marrow function",
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}
}
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"exact_snippets": "Adequate organ ... function",
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"expected_value": true
}
},
{
"exact_snippets": "Adequate ... bone marrow function",
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]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
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{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"expected_value": "healthy"
}
}
]
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"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
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{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
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}
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},
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{
"exact_snippets": "minimum age of 18 Years",
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"unit": "Years"
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]
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],
"exclusion_lines": [
{
"identified_line": {
"line": "* Chemotherapy within past 3 weeks of initiation of therapy",
"criterions": [
{
"exact_snippets": "Chemotherapy within past 3 weeks",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Chemotherapy within past 3 weeks",
"criterion": "chemotherapy",
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"expected_value": {
"operator": "<=",
"value": 3,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Clinically apparent central nervous system metastases or carcinomatous meningitis",
"criterions": [
{
"exact_snippets": "Clinically apparent central nervous system metastases",
"criterion": "central nervous system metastases",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "carcinomatous meningitis",
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}
]
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}
},
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}
}
]
}
},
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"exact_snippets": "Biliary obstruction with inadequate drainage",
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}
},
{
"exact_snippets": "total bilirubin > 2.5 mg/dL",
"criterion": "total bilirubin",
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"operator": ">",
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}
}
}
]
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"and_criteria": [
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}
},
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}
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"identified_line": {
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}
]
}
},
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"identified_line": {
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{
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}
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"identified_line": {
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"exact_snippets": "Blood pressure of > 150/100 mmHg",
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"exact_snippets": "Blood pressure of > 150/100 mmHg",
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"identified_line": {
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"exact_snippets": "Unstable angina",
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]
},
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"exact_snippets": "Unstable angina",
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}
}
},
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"identified_line": {
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"exact_snippets": "NYHA Grade II or greater congestive heart failure",
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"identified_line": {
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}
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{
"exact_snippets": "Clinically significant peripheral vascular disease",
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}
}
]
},
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"exact_snippets": "Clinically significant peripheral vascular disease",
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Evidence of bleeding diathesis",
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"expected_value": true
}
},
{
"exact_snippets": "Evidence of ... coagulopathy",
"criterion": "coagulopathy",
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"expected_value": true
}
}
]
},
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"exact_snippets": "Evidence of bleeding diathesis",
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}
},
{
"exact_snippets": "Evidence of ... coagulopathy",
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}
}
]
}
},
{
"identified_line": {
"line": "* Major surgical procedure, open biopsy, or significant traumatic injury with 28 days prior to Day 1, anticipation of need for major surgical procedure during the course of the study",
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{
"exact_snippets": "Major surgical procedure, open biopsy, or significant traumatic injury with 28 days prior to Day 1",
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