{
"info": {
"nct_id": "NCT00331682",
"official_title": "An Open-Label, Non-Randomized Phase II Study of Alvocidib (Flavopiridol) in Combination With Docetaxel in Refractory, Metastatic Pancreatic Cancer (NCI #6366)",
"inclusion_criteria": "* Histologically or cytologically confirmed adenocarcinoma of the pancreas\n\n * Evidence of metastatic disease\n* Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20mm with conventional techniques or as ≥ 10 mm with spiral CT scan\n\n * The primary site is not a measurable lesion\n* Documented progression with measurable metastatic disease including any 1 of the following criteria:\n\n * Receiving adjuvant therapy for resected disease\n * Receiving therapy for locally advanced disease\n * Within 3 months of completing adjuvant therapy or therapy for locally advanced disease\n * On 1 prior regimen in the metastatic setting\n* No documented brain metastases\n* Karnofsky performance status (PS) 80-100% OR ECOG PS 0-1\n* WBC ≥ 2,500/mm³\n* Absolute neutrophil count ≥ 1,500/mm³\n* Platelet count ≥ 100,000/mm³\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* AST and ALT < 2.5 times ULN\n* Creatinine normal OR creatinine clearance ≥ 60 mL/min\n* Alkaline phosphatase ≤ 5 times ULN\n* No history of allergic reactions to compounds of similar chemical orbiological composition to flavopiridol\n* No known allergy to docetaxel or medications formulated in polysorbate 80 (Tween 80)\n* No uncontrolled diabetes\n* No uncontrolled intercurrent illness including, but not limited to any of the following:\n\n * Ongoing or active infection\n * Symptomatic congestive heart failure\n * Unstable angina pectoris\n * Cardiac arrhythmia or myocardial infarction within the past 6 months\n\n * Rate-controlled atrial fibrillation stable for ≥ 6 months allowed\n * Psychiatric illness or social situations that would limit compliance with study requirements\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 3 months after completion of study treatment\n* No peripheral neuropathy > grade 1\n* No immune deficiency\n* Atl east 2 weeks since prior chemotherapy (6 weeks for nitrosoureas, carmustine, or mitomycin C) and recovered\n* At least 2 weeks since prior targeted therapy (e.g., antiangiogenic therapy [e.g., bevacizumab] or epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [e.g., erlotinib hydrochloride]) and recovered\n* At least 4 weeks since prior radiation therapy\n* No prior docetaxel or flavopiridol\n* No other concurrent chemotherapy or investigational agents\n* No other concurrent anticancer agents or therapies\n* No concurrent commonly used vitamins, antioxidants, orherbal preparations or supplements\n\n * Single-tablet multivitamin allowed\n* No concurrent combination antiretroviral therapy for HIV-positive patients\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Histologically or cytologically confirmed adenocarcinoma of the pancreas",
"criterions": [
{
"exact_snippets": "Histologically or cytologically confirmed adenocarcinoma of the pancreas",
"criterion": "adenocarcinoma of the pancreas",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": [
"histologically",
"cytologically"
]
}
]
}
]
},
{
"line": "* Evidence of metastatic disease",
"criterions": [
{
"exact_snippets": "Evidence of metastatic disease",
"criterion": "metastatic disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20mm with conventional techniques or as ≥ 10 mm with spiral CT scan",
"criterions": [
{
"exact_snippets": "Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20mm with conventional techniques",
"criterion": "measurable disease",
"requirements": [
{
"requirement_type": "measurement",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "mm"
}
}
]
},
{
"exact_snippets": "Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) ... as ≥ 10 mm with spiral CT scan",
"criterion": "measurable disease",
"requirements": [
{
"requirement_type": "measurement",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "mm"
}
}
]
}
]
},
{
"line": "* The primary site is not a measurable lesion",
"criterions": [
{
"exact_snippets": "The primary site is not a measurable lesion",
"criterion": "primary site",
"requirements": [
{
"requirement_type": "measurability",
"expected_value": false
}
]
}
]
},
{
"line": "* Documented progression with measurable metastatic disease including any 1 of the following criteria:",
"criterions": [
{
"exact_snippets": "Documented progression",
"criterion": "disease progression",
"requirements": [
{
"requirement_type": "documentation",
"expected_value": true
}
]
},
{
"exact_snippets": "measurable metastatic disease",
"criterion": "metastatic disease",
"requirements": [
{
"requirement_type": "measurability",
"expected_value": true
}
]
}
]
},
{
"line": "* Receiving adjuvant therapy for resected disease",
"criterions": [
{
"exact_snippets": "Receiving adjuvant therapy",
"criterion": "adjuvant therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "resected disease",
"criterion": "resected disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Receiving therapy for locally advanced disease",
"criterions": [
{
"exact_snippets": "Receiving therapy for locally advanced disease",
"criterion": "therapy for locally advanced disease",
"requirements": [
{
"requirement_type": "status",
"expected_value": "receiving"
}
]
}
]
},
{
"line": "* Within 3 months of completing adjuvant therapy or therapy for locally advanced disease",
"criterions": [
{
"exact_snippets": "Within 3 months of completing adjuvant therapy",
"criterion": "completion of adjuvant therapy",
"requirements": [
{
"requirement_type": "time since completion",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
]
},
{
"exact_snippets": "Within 3 months of completing ... therapy for locally advanced disease",
"criterion": "completion of therapy for locally advanced disease",
"requirements": [
{
"requirement_type": "time since completion",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
]
}
]
},
{
"line": "* On 1 prior regimen in the metastatic setting",
"criterions": [
{
"exact_snippets": "1 prior regimen in the metastatic setting",
"criterion": "prior regimen",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 1,
"unit": "N/A"
}
},
{
"requirement_type": "setting",
"expected_value": "metastatic"
}
]
}
]
},
{
"line": "* No documented brain metastases",
"criterions": [
{
"exact_snippets": "No documented brain metastases",
"criterion": "brain metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Karnofsky performance status (PS) 80-100% OR ECOG PS 0-1",
"criterions": [
{
"exact_snippets": "Karnofsky performance status (PS) 80-100%",
"criterion": "Karnofsky performance status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 80,
"unit": "%"
},
{
"operator": "<=",
"value": 100,
"unit": "%"
}
]
}
}
]
},
{
"exact_snippets": "ECOG PS 0-1",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* WBC ≥ 2,500/mm³",
"criterions": [
{
"exact_snippets": "WBC ≥ 2,500/mm³",
"criterion": "WBC",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2500,
"unit": "mm³"
}
}
]
}
]
},
{
"line": "* Absolute neutrophil count ≥ 1,500/mm³",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count ≥ 1,500/mm³",
"criterion": "absolute neutrophil count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm³"
}
}
]
}
]
},
{
"line": "* Platelet count ≥ 100,000/mm³",
"criterions": [
{
"exact_snippets": "Platelet count ≥ 100,000/mm³",
"criterion": "platelet count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm³"
}
}
]
}
]
},
{
"line": "* Bilirubin ≤ 1.5 times upper limit of normal (ULN)",
"criterions": [
{
"exact_snippets": "Bilirubin ≤ 1.5 times upper limit of normal (ULN)",
"criterion": "bilirubin level",
"requirements": [
{
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times ULN"
}
}
]
}
]
},
{
"line": "* AST and ALT < 2.5 times ULN",
"criterions": [
{
"exact_snippets": "AST and ALT < 2.5 times ULN",
"criterion": "AST",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 2.5,
"unit": "times ULN"
}
}
]
},
{
"exact_snippets": "AST and ALT < 2.5 times ULN",
"criterion": "ALT",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 2.5,
"unit": "times ULN"
}
}
]
}
]
},
{
"line": "* Creatinine normal OR creatinine clearance ≥ 60 mL/min",
"criterions": [
{
"exact_snippets": "Creatinine normal",
"criterion": "creatinine",
"requirements": [
{
"requirement_type": "level",
"expected_value": "normal"
}
]
},
{
"exact_snippets": "creatinine clearance ≥ 60 mL/min",
"criterion": "creatinine clearance",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "mL/min"
}
}
]
}
]
},
{
"line": "* Alkaline phosphatase ≤ 5 times ULN",
"criterions": [
{
"exact_snippets": "Alkaline phosphatase ≤ 5 times ULN",
"criterion": "alkaline phosphatase",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "times ULN"
}
}
]
}
]
},
{
"line": "* No known allergy to docetaxel or medications formulated in polysorbate 80 (Tween 80)",
"criterions": [
{
"exact_snippets": "No known allergy to docetaxel",
"criterion": "allergy to docetaxel",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No known allergy to ... medications formulated in polysorbate 80 (Tween 80)",
"criterion": "allergy to medications formulated in polysorbate 80 (Tween 80)",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No uncontrolled diabetes",
"criterions": [
{
"exact_snippets": "uncontrolled diabetes",
"criterion": "diabetes",
"requirements": [
{
"requirement_type": "control",
"expected_value": true
}
]
}
]
},
{
"line": "* No uncontrolled intercurrent illness including, but not limited to any of the following:",
"criterions": [
{
"exact_snippets": "uncontrolled intercurrent illness",
"criterion": "intercurrent illness",
"requirements": [
{
"requirement_type": "control",
"expected_value": false
}
]
}
]
},
{
"line": "* Ongoing or active infection",
"criterions": [
{
"exact_snippets": "Ongoing or active infection",
"criterion": "infection",
"requirements": [
{
"requirement_type": "status",
"expected_value": [
"ongoing",
"active"
]
}
]
}
]
},
{
"line": "* Symptomatic congestive heart failure",
"criterions": [
{
"exact_snippets": "Symptomatic congestive heart failure",
"criterion": "congestive heart failure",
"requirements": [
{
"requirement_type": "symptomatic",
"expected_value": true
}
]
}
]
},
{
"line": "* Unstable angina pectoris",
"criterions": [
{
"exact_snippets": "Unstable angina pectoris",
"criterion": "angina pectoris",
"requirements": [
{
"requirement_type": "stability",
"expected_value": "unstable"
}
]
}
]
},
{
"line": "* Cardiac arrhythmia or myocardial infarction within the past 6 months",
"criterions": [
{
"exact_snippets": "Cardiac arrhythmia",
"criterion": "cardiac arrhythmia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "myocardial infarction",
"criterion": "myocardial infarction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
},
{
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Rate-controlled atrial fibrillation stable for ≥ 6 months allowed",
"criterions": [
{
"exact_snippets": "Rate-controlled atrial fibrillation stable for ≥ 6 months",
"criterion": "rate-controlled atrial fibrillation",
"requirements": [
{
"requirement_type": "stability duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Psychiatric illness or social situations that would limit compliance with study requirements",
"criterions": [
{
"exact_snippets": "Psychiatric illness",
"criterion": "psychiatric illness",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "social situations that would limit compliance with study requirements",
"criterion": "social situations",
"requirements": [
{
"requirement_type": "impact on compliance",
"expected_value": "would not limit"
}
]
}
]
},
{
"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 during and for 3 months after completion of study treatment",
"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
}
]
},
{
"exact_snippets": "during and for 3 months after completion of study treatment",
"criterion": "contraception duration",
"requirements": [
{
"requirement_type": "duration",
"expected_value": "during and for 3 months after completion of study treatment"
}
]
}
]
},
{
"line": "* No peripheral neuropathy > grade 1",
"criterions": [
{
"exact_snippets": "No peripheral neuropathy > grade 1",
"criterion": "peripheral neuropathy",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "grade"
}
}
]
}
]
},
{
"line": "* No immune deficiency",
"criterions": [
{
"exact_snippets": "No immune deficiency",
"criterion": "immune deficiency",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* At least 2 weeks since prior targeted therapy (e.g., antiangiogenic therapy [e.g., bevacizumab] or epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [e.g., erlotinib hydrochloride]) and recovered",
"criterions": [
{
"exact_snippets": "At least 2 weeks since prior targeted therapy",
"criterion": "time since prior targeted therapy",
"requirements": [
{
"requirement_type": "time since",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "recovered",
"criterion": "recovery from prior targeted therapy",
"requirements": [
{
"requirement_type": "recovery status",
"expected_value": true
}
]
}
]
},
{
"line": "* At least 4 weeks since prior radiation therapy",
"criterions": [
{
"exact_snippets": "At least 4 weeks since prior radiation therapy",
"criterion": "time since prior radiation therapy",
"requirements": [
{
"requirement_type": "time elapsed",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
]
}
]
},
{
"line": "* No prior docetaxel or flavopiridol",
"criterions": [
{
"exact_snippets": "No prior docetaxel",
"criterion": "prior docetaxel",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No prior ... flavopiridol",
"criterion": "prior flavopiridol",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No other concurrent chemotherapy or investigational agents",
"criterions": [
{
"exact_snippets": "No other concurrent chemotherapy",
"criterion": "concurrent chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No other concurrent ... investigational agents",
"criterion": "concurrent investigational agents",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No other concurrent anticancer agents or therapies",
"criterions": [
{
"exact_snippets": "No other concurrent anticancer agents or therapies",
"criterion": "concurrent anticancer agents or therapies",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No concurrent commonly used vitamins, antioxidants, orherbal preparations or supplements",
"criterions": [
{
"exact_snippets": "No concurrent commonly used vitamins",
"criterion": "concurrent use of vitamins",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No concurrent ... antioxidants",
"criterion": "concurrent use of antioxidants",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No concurrent ... herbal preparations or supplements",
"criterion": "concurrent use of herbal preparations or supplements",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Single-tablet multivitamin allowed",
"criterions": [
{
"exact_snippets": "Single-tablet multivitamin allowed",
"criterion": "multivitamin",
"requirements": [
{
"requirement_type": "allowance",
"expected_value": true
}
]
}
]
},
{
"line": "* No concurrent combination antiretroviral therapy for HIV-positive patients",
"criterions": [
{
"exact_snippets": "No concurrent combination antiretroviral therapy for HIV-positive patients",
"criterion": "combination antiretroviral therapy",
"requirements": [
{
"requirement_type": "concurrency",
"expected_value": false
}
]
}
]
},
{
"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"
}
}
]
}
]
}
],
"exclusion_lines": [],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "* No history of allergic reactions to compounds of similar chemical orbiological composition to flavopiridol",
"criterions": [
{
"exact_snippets": "No history of allergic reactions to compounds of similar chemical or biological composition to flavopiridol",
"criterion": "allergic reactions",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
},
{
"requirement_type": "composition similarity",
"expected_value": "similar to flavopiridol"
}
]
}
]
},
{
"line": "* Not pregnant or nursing",
"criterions": [
{
"exact_snippets": "Not pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
},
{
"exact_snippets": "not ... nursing",
"criterion": "nursing",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
}
]
},
{
"line": "* Atl east 2 weeks since prior chemotherapy (6 weeks for nitrosoureas, carmustine, or mitomycin C) and recovered",
"criterions": [
{
"exact_snippets": "At least 2 weeks since prior chemotherapy",
"criterion": "time since prior chemotherapy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "6 weeks for nitrosoureas, carmustine, or mitomycin C",
"criterion": "time since prior nitrosoureas, carmustine, or mitomycin C",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "recovered",
"criterion": "recovery from prior chemotherapy",
"requirements": [
{
"requirement_type": "status",
"expected_value": "recovered"
}
]
}
]
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}