{
    "info": {
        "nct_id": "NCT00022620",
        "official_title": "Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC)",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have maximum age of 75 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed endometrial papillary carcinoma (uterine papillary serous carcinoma)\n\n  * Progressive or recurrent\n* Bidimensionally measurable disease\n* Platinum refractory disease, defined by one of the following:\n\n  * Progression during platinum-based chemotherapy\n  * Stable disease for at least 4 courses of platinum-based chemotherapy\n  * Recurrence within 4 months of platinum-based chemotherapy\n* No brain involvement or leptomeningeal disease\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 75 and under\n\nPerformance status:\n\n* WHO 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Neutrophil count at least 1,500/mm3\n* Platelet count at least 100,000/mm3\n\nHepatic:\n\n* Bilirubin no greater than 50 umol/L\n\nRenal:\n\n* BUN no greater than 8.0 mmol/L\n* Creatinine no greater than 120 umol/L\n* Creatinine clearance at least 60 mL/min\n\nOther:\n\n* Not pregnant\n* Fertile patients must use effective contraception\n* HIV negative\n* No other prior or concurrent malignancy except basal cell carcinoma of the skin\n* No active bacterial infection (e.g., urinary tract infection)\n* No uncontrolled or potentially active site of infection (e.g., fistula or abscess)\n* No psychological, familial, sociological, or geographical condition that would preclude study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior chemotherapy\n* At least 1 prior platinum containing regimen\n* At least 50 mg/m2 per course for a maximum of 28 days for cisplatin\n* At least 5 times AUC for a maximum of 4 weeks per course for carboplatin\n* Prior non-taxane-containing chemotherapy allowed\n\nEndocrine therapy:\n\n* At least 4 weeks since prior hormonal therapy\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy\n* At least 3 months since prior radiotherapy to target lesion\n* Concurrent radiotherapy allowed for bone pain provided evaluable lesions are outside of irradiation field)\n\nSurgery:\n\n* Prior surgical management of lymph nodes allowed"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Histologically confirmed endometrial papillary carcinoma (uterine papillary serous carcinoma)",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed endometrial papillary carcinoma (uterine papillary serous carcinoma)",
                    "criterion": "endometrial papillary carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressive or recurrent",
            "criterions": [
                {
                    "exact_snippets": "Progressive or recurrent",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "progressive",
                                "recurrent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bidimensionally measurable disease",
            "criterions": [
                {
                    "exact_snippets": "Bidimensionally measurable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "bidimensional"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platinum refractory disease, defined by one of the following:",
            "criterions": [
                {
                    "exact_snippets": "Platinum refractory disease",
                    "criterion": "platinum refractory disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progression during platinum-based chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Progression during platinum-based chemotherapy",
                    "criterion": "progression",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "platinum-based chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stable disease for at least 4 courses of platinum-based chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Stable disease for at least 4 courses of platinum-based chemotherapy",
                    "criterion": "disease stability",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "courses of platinum-based chemotherapy"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recurrence within 4 months of platinum-based chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Recurrence within 4 months of platinum-based chemotherapy",
                    "criterion": "recurrence",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "months"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "platinum-based chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No brain involvement or leptomeningeal disease",
            "criterions": [
                {
                    "exact_snippets": "No brain involvement",
                    "criterion": "brain involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age:",
            "criterions": [
                {
                    "exact_snippets": "Age:",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 75 and under",
            "criterions": [
                {
                    "exact_snippets": "75 and under",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Performance status:",
            "criterions": [
                {
                    "exact_snippets": "Performance status:",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WHO 0-2",
            "criterions": [
                {
                    "exact_snippets": "WHO 0-2",
                    "criterion": "WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Life expectancy:",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hematopoietic:",
            "criterions": [
                {
                    "exact_snippets": "Hematopoietic:",
                    "criterion": "hematopoietic system",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neutrophil count at least 1,500/mm3",
            "criterions": [
                {
                    "exact_snippets": "Neutrophil count at least 1,500/mm3",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count at least 100,000/mm3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count at least 100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic:",
            "criterions": [
                {
                    "exact_snippets": "Hepatic:",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin no greater than 50 umol/L",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin no greater than 50 umol/L",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 50,
                                "unit": "umol/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal:",
            "criterions": [
                {
                    "exact_snippets": "Renal:",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* BUN no greater than 8.0 mmol/L",
            "criterions": [
                {
                    "exact_snippets": "BUN no greater than 8.0 mmol/L",
                    "criterion": "BUN",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8.0,
                                "unit": "mmol/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine no greater than 120 umol/L",
            "criterions": [
                {
                    "exact_snippets": "Creatinine no greater than 120 umol/L",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "umol/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine clearance at least 60 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance at least 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not pregnant",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception",
            "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
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HIV negative",
            "criterions": [
                {
                    "exact_snippets": "HIV negative",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other prior or concurrent malignancy except basal cell carcinoma of the skin",
            "criterions": [
                {
                    "exact_snippets": "No other prior or concurrent malignancy",
                    "criterion": "prior or concurrent malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active bacterial infection (e.g., urinary tract infection)",
            "criterions": [
                {
                    "exact_snippets": "No active bacterial infection",
                    "criterion": "bacterial infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "urinary tract infection",
                    "criterion": "urinary tract infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncontrolled or potentially active site of infection (e.g., fistula or abscess)",
            "criterions": [
                {
                    "exact_snippets": "No uncontrolled or potentially active site of infection",
                    "criterion": "site of infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No psychological, familial, sociological, or geographical condition that would preclude study",
            "criterions": [
                {
                    "exact_snippets": "No psychological ... condition that would preclude study",
                    "criterion": "psychological condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... familial ... condition that would preclude study",
                    "criterion": "familial condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... sociological ... condition that would preclude study",
                    "criterion": "sociological condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... geographical condition that would preclude study",
                    "criterion": "geographical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Biologic therapy:",
            "criterions": [
                {
                    "exact_snippets": "Biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chemotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "see details"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks since prior chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since prior chemotherapy",
                    "criterion": "time since prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 1 prior platinum containing regimen",
            "criterions": [
                {
                    "exact_snippets": "At least 1 prior platinum containing regimen",
                    "criterion": "prior platinum containing regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 50 mg/m2 per course for a maximum of 28 days for cisplatin",
            "criterions": [
                {
                    "exact_snippets": "At least 50 mg/m2 per course ... for cisplatin",
                    "criterion": "cisplatin dosage",
                    "requirements": [
                        {
                            "requirement_type": "minimum dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mg/m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "maximum of 28 days",
                    "criterion": "treatment duration",
                    "requirements": [
                        {
                            "requirement_type": "maximum duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 5 times AUC for a maximum of 4 weeks per course for carboplatin",
            "criterions": [
                {
                    "exact_snippets": "At least 5 times AUC",
                    "criterion": "AUC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "times"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "maximum of 4 weeks per course",
                    "criterion": "course duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "carboplatin",
                    "criterion": "carboplatin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior non-taxane-containing chemotherapy allowed",
            "criterions": [
                {
                    "exact_snippets": "Prior non-taxane-containing chemotherapy allowed",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-taxane-containing"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "allowed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Endocrine therapy:",
            "criterions": [
                {
                    "exact_snippets": "Endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks since prior hormonal therapy",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since prior hormonal therapy",
                    "criterion": "time since prior hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Radiotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks since prior radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since prior radiotherapy",
                    "criterion": "time since prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 3 months since prior radiotherapy to target lesion",
            "criterions": [
                {
                    "exact_snippets": "At least 3 months since prior radiotherapy to target lesion",
                    "criterion": "prior radiotherapy to target lesion",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent radiotherapy allowed for bone pain provided evaluable lesions are outside of irradiation field)",
            "criterions": [
                {
                    "exact_snippets": "Concurrent radiotherapy allowed",
                    "criterion": "concurrent radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evaluable lesions are outside of irradiation field",
                    "criterion": "evaluable lesions location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "outside of irradiation field"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery:",
            "criterions": [
                {
                    "exact_snippets": "Surgery:",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior surgical management of lymph nodes allowed",
            "criterions": [
                {
                    "exact_snippets": "Prior surgical management of lymph nodes allowed",
                    "criterion": "surgical management of lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other:",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        }
    ]
}