{
"info": {
"nct_id": "NCT00354601",
"official_title": "A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum",
"inclusion_criteria": "DISEASE CHARACTERISTICS:\n\n* Diagnosis of 1 of the following:\n\n * Ovarian epithelial adenocarcinoma\n * Fallopian tube cancer\n * Peritoneal cavity cancer\n* Recurrent or persistent disease after no more than 2 prior treatment regimens (1 regimen for primary disease and/or 1 regimen for recurrent disease)\n* Platinum-resistant disease, defined as 1 of the following:\n\n * Treatment-free interval < 6 months after platinum-based therapy\n * Disease progression during platinum-based therapy\n* Measurable disease by physical exam, chest x-ray, CT scan, or MRI\n* No brain metastases\n\nPATIENT CHARACTERISTICS:\n\n* Gynecologic Oncology Group performance status 0-2\n* Life expectancy > 6 months\n* Absolute neutrophil count ≥ 1,500/mm³\n* Platelet count ≥ 100,000/mm³\n* Hemoglobin ≥ 8 g/dL\n* Creatinine clearance ≥ 50 mL/min\n* Bilirubin normal\n* AST or ALT and alkaline phosphatase (AP) meeting 1 of the following criteria:\n\n * AST or ALT ≤ 5 times upper limit of normal (ULN) AND AP normal\n * AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN\n * AST or ALT normal AND AP ≤ 5 times ULN\n* No peripheral neuropathy > grade 2\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 6 months after completion of study treatment\n* No other concurrent malignancy except for curatively treated nonmelanoma skin cancer\n* No prior invasive malignancy < 5 years after curative therapy\n* No serious uncontrolled medical or psychiatric illness that would preclude study participation or limit survival to < 6 months\n* No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 or to fluoropyrimidine therapy or fluorouracil\n* No inability to tolerate oral medication due to bowel obstruction, lack of physical integrity of the upper gastrointestinal tract, inability to swallow, or malabsorption syndrome\n* No serious concurrent infections\n* No clinically significant cardiac disease not well controlled with medication, including any of the following:\n\n * Congestive heart failure\n * Symptomatic coronary artery disease\n * Symptomatic cardiac arrhythmias\n * Myocardial infarction within the past 12 months\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior docetaxel or capecitabine or other fluoropyrimidine therapy\n* Recovered from prior therapy\n* At least 2 weeks since prior major surgery\n* At least 4 weeks since prior chemotherapy, hormone therapy, or radiotherapy\n* No other concurrent chemotherapeutic agents, biological therapy, radiotherapy, or other investigational agents\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "DISEASE CHARACTERISTICS:",
"criterions": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* Diagnosis of 1 of the following:",
"criterions": [
{
"exact_snippets": "Diagnosis of 1 of the following",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Diagnosis of 1 of the following",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Ovarian epithelial adenocarcinoma",
"criterions": [
{
"exact_snippets": "Ovarian epithelial adenocarcinoma",
"criterion": "ovarian epithelial adenocarcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Ovarian epithelial adenocarcinoma",
"criterion": "ovarian epithelial adenocarcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Fallopian tube cancer",
"criterions": [
{
"exact_snippets": "Fallopian tube cancer",
"criterion": "fallopian tube cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Fallopian tube cancer",
"criterion": "fallopian tube cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Peritoneal cavity cancer",
"criterions": [
{
"exact_snippets": "Peritoneal cavity cancer",
"criterion": "peritoneal cavity cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Peritoneal cavity cancer",
"criterion": "peritoneal cavity cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Recurrent or persistent disease after no more than 2 prior treatment regimens (1 regimen for primary disease and/or 1 regimen for recurrent disease)",
"criterions": [
{
"exact_snippets": "Recurrent or persistent disease",
"criterion": "disease status",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"recurrent",
"persistent"
]
}
},
{
"exact_snippets": "no more than 2 prior treatment regimens",
"criterion": "prior treatment regimens",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "regimens"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Recurrent or persistent disease",
"criterion": "disease status",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"recurrent",
"persistent"
]
}
},
{
"exact_snippets": "no more than 2 prior treatment regimens",
"criterion": "prior treatment regimens",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "regimens"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Platinum-resistant disease, defined as 1 of the following:",
"criterions": [
{
"exact_snippets": "Platinum-resistant disease",
"criterion": "platinum-resistant disease",
"requirement": {
"requirement_type": "definition",
"expected_value": "1 of the following"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Platinum-resistant disease",
"criterion": "platinum-resistant disease",
"requirement": {
"requirement_type": "definition",
"expected_value": "1 of the following"
}
}
]
}
},
{
"identified_line": {
"line": "* Treatment-free interval < 6 months after platinum-based therapy",
"criterions": [
{
"exact_snippets": "Treatment-free interval < 6 months",
"criterion": "treatment-free interval",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "after platinum-based therapy",
"criterion": "prior therapy",
"requirement": {
"requirement_type": "type",
"expected_value": "platinum-based"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Treatment-free interval < 6 months",
"criterion": "treatment-free interval",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "after platinum-based therapy",
"criterion": "prior therapy",
"requirement": {
"requirement_type": "type",
"expected_value": "platinum-based"
}
}
]
}
},
{
"identified_line": {
"line": "* Disease progression during platinum-based therapy",
"criterions": [
{
"exact_snippets": "Disease progression during platinum-based therapy",
"criterion": "disease progression",
"requirement": {
"requirement_type": "timing",
"expected_value": "during platinum-based therapy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Disease progression during platinum-based therapy",
"criterion": "disease progression",
"requirement": {
"requirement_type": "timing",
"expected_value": "during platinum-based therapy"
}
}
]
}
},
{
"identified_line": {
"line": "* No brain metastases",
"criterions": [
{
"exact_snippets": "No brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Gynecologic Oncology Group performance status 0-2",
"criterions": [
{
"exact_snippets": "Gynecologic Oncology Group performance status 0-2",
"criterion": "Gynecologic Oncology Group performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Gynecologic Oncology Group performance status 0-2",
"criterion": "Gynecologic Oncology Group performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Life expectancy > 6 months",
"criterions": [
{
"exact_snippets": "Life expectancy > 6 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 6,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Life expectancy > 6 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 6,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Absolute neutrophil count ≥ 1,500/mm³",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count ≥ 1,500/mm³",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm³"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Absolute neutrophil count ≥ 1,500/mm³",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm³"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Platelet count ≥ 100,000/mm³",
"criterions": [
{
"exact_snippets": "Platelet count ≥ 100,000/mm³",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm³"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Platelet count ≥ 100,000/mm³",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm³"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Hemoglobin ≥ 8 g/dL",
"criterions": [
{
"exact_snippets": "Hemoglobin ≥ 8 g/dL",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 8,
"unit": "g/dL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hemoglobin ≥ 8 g/dL",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 8,
"unit": "g/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Creatinine clearance ≥ 50 mL/min",
"criterions": [
{
"exact_snippets": "Creatinine clearance ≥ 50 mL/min",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "mL/min"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Creatinine clearance ≥ 50 mL/min",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "mL/min"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Bilirubin normal",
"criterions": [
{
"exact_snippets": "Bilirubin normal",
"criterion": "bilirubin level",
"requirement": {
"requirement_type": "level",
"expected_value": "normal"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Bilirubin normal",
"criterion": "bilirubin level",
"requirement": {
"requirement_type": "level",
"expected_value": "normal"
}
}
]
}
},
{
"identified_line": {
"line": "* AST or ALT and alkaline phosphatase (AP) meeting 1 of the following criteria:",
"criterions": [
{
"exact_snippets": "AST or ALT",
"criterion": "AST or ALT",
"requirement": {
"requirement_type": "level",
"expected_value": "meeting 1 of the following criteria"
}
},
{
"exact_snippets": "alkaline phosphatase (AP)",
"criterion": "alkaline phosphatase (AP)",
"requirement": {
"requirement_type": "level",
"expected_value": "meeting 1 of the following criteria"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "AST or ALT",
"criterion": "AST or ALT",
"requirement": {
"requirement_type": "level",
"expected_value": "meeting 1 of the following criteria"
}
},
{
"exact_snippets": "alkaline phosphatase (AP)",
"criterion": "alkaline phosphatase (AP)",
"requirement": {
"requirement_type": "level",
"expected_value": "meeting 1 of the following criteria"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN",
"criterions": [
{
"exact_snippets": "AST or ALT ≤ 1.5 times ULN",
"criterion": "AST or ALT levels",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times ULN"
}
}
},
{
"exact_snippets": "AP ≤ 2.5 times ULN",
"criterion": "AP levels",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "times ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "AST or ALT ≤ 1.5 times ULN",
"criterion": "AST or ALT levels",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times ULN"
}
}
},
{
"exact_snippets": "AP ≤ 2.5 times ULN",
"criterion": "AP levels",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "times ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "* AST or ALT normal AND AP ≤ 5 times ULN",
"criterions": [
{
"exact_snippets": "AST or ALT normal",
"criterion": "AST or ALT levels",
"requirement": {
"requirement_type": "level",
"expected_value": "normal"
}
},
{
"exact_snippets": "AP ≤ 5 times ULN",
"criterion": "AP levels",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "times ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "AST or ALT normal",
"criterion": "AST or ALT levels",
"requirement": {
"requirement_type": "level",
"expected_value": "normal"
}
},
{
"exact_snippets": "AP ≤ 5 times ULN",
"criterion": "AP levels",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "times ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "* No serious concurrent infections",
"criterions": [
{
"exact_snippets": "No serious concurrent infections",
"criterion": "concurrent infections",
"requirement": {
"requirement_type": "severity",
"expected_value": "not serious"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No serious concurrent infections",
"criterion": "concurrent infections",
"requirement": {
"requirement_type": "severity",
"expected_value": "not serious"
}
}
]
}
},
{
"identified_line": {
"line": "* Congestive heart failure",
"criterions": [
{
"exact_snippets": "Congestive heart failure",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Congestive heart failure",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Symptomatic coronary artery disease",
"criterions": [
{
"exact_snippets": "Symptomatic coronary artery disease",
"criterion": "coronary artery disease",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Symptomatic coronary artery disease",
"criterion": "coronary artery disease",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Symptomatic cardiac arrhythmias",
"criterions": [
{
"exact_snippets": "Symptomatic cardiac arrhythmias",
"criterion": "cardiac arrhythmias",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Symptomatic cardiac arrhythmias",
"criterion": "cardiac arrhythmias",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Myocardial infarction within the past 12 months",
"criterions": [
{
"exact_snippets": "Myocardial infarction within the past 12 months",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "occurrence",
"expected_value": {
"operator": "<=",
"value": 12,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Myocardial infarction within the past 12 months",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "occurrence",
"expected_value": {
"operator": "<=",
"value": 12,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "PRIOR CONCURRENT THERAPY:",
"criterions": [
{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
"criterion": "prior concurrent therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
"criterion": "prior concurrent therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* See Disease Characteristics",
"criterions": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "refer to disease characteristics section"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "refer to disease characteristics section"
}
}
]
}
},
{
"identified_line": {
"line": "* No prior docetaxel or capecitabine or other fluoropyrimidine therapy",
"criterions": [
{
"exact_snippets": "No prior docetaxel",
"criterion": "prior docetaxel therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No prior ... capecitabine",
"criterion": "prior capecitabine therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No prior ... other fluoropyrimidine therapy",
"criterion": "prior other fluoropyrimidine therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "No prior docetaxel",
"criterion": "prior docetaxel therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No prior ... capecitabine",
"criterion": "prior capecitabine therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "No prior ... other fluoropyrimidine therapy",
"criterion": "prior other fluoropyrimidine therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Recovered from prior therapy",
"criterions": [
{
"exact_snippets": "Recovered from prior therapy",
"criterion": "recovery from prior therapy",
"requirement": {
"requirement_type": "status",
"expected_value": "recovered"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Recovered from prior therapy",
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