{
    "info": {
        "nct_id": "NCT00377520",
        "official_title": "A Phase II Evaluation of Pemetrexed in the Treatment of Recurrent or Persistent Endometrial Carcinoma",
        "inclusion_criteria": "* Patients must have recurrent or persistent endometrial adenocarcinoma, which is refractory to curative therapy or established treatments.\n* Patients must have measurable disease.\n* Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma.\n* Patients must have signed an approved informed consent.\n* Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception during the study and for at least 3 months following the last dose of Pemetrexed.\n* Patients must discontinue nonsteroidal anti-inflammatory (NSAIDs) medications 2-5 days prior to and for 1-2 days after receiving Pemetrexed, depending on the half-life of the NSAIDs treatment.\n* Patients must agree to this schedule in conjunction with every dose of Pemetrexed.\n* Patients must receive 350-1000 mcg of folic acid (e.g. one prenatal vitamin) starting 7 days prior to the first treatment with Pemetrexed.\n* Patients must be able to ingest 350-1000 mcg of folic acid daily until 3 weeks after the last dose of Pemetrexed.\n* Patients must receive 4 mg Dexamethasone by mouth twice daily, 1 day prior to the dose, the day of and the day after every dose of Pemetrexed.\n* Patients must receive a 1000 mcg vitamin B12 injection 7 days prior to receiving the first treatment with Pemetrexed.\n* Patients must agree to receive 1000 mcg vitamin B12 injection every 9 weeks until 3 weeks after the last dose of Pemetrexed.\nHealthy volunteers allowed\nMust be FEMALE",
        "exclusion_criteria": "* Patients who have had prior therapy with Pemetrexed\n* Patients who have received radiation to more than 25% of marrow bearing areas",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must have recurrent or persistent endometrial adenocarcinoma, which is refractory to curative therapy or established treatments.",
            "criterions": [
                {
                    "exact_snippets": "recurrent or persistent endometrial adenocarcinoma",
                    "criterion": "endometrial adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "persistence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to curative therapy or established treatments",
                    "criterion": "refractory to treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "curative therapy",
                                "established treatments"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have measurable disease.",
            "criterions": [
                {
                    "exact_snippets": "measurable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Patients must have had one prior chemotherapeutic regimen",
                    "criterion": "prior chemotherapeutic regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "management of endometrial carcinoma",
                    "criterion": "endometrial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "management",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have signed an approved informed consent.",
            "criterions": [
                {
                    "exact_snippets": "signed an approved informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception during the study and for at least 3 months following the last dose of Pemetrexed.",
            "criterions": [
                {
                    "exact_snippets": "Patients of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum pregnancy test prior to the study entry",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "practicing an effective form of contraception during the study and for at least 3 months following the last dose of Pemetrexed",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study and for at least 3 months following the last dose of Pemetrexed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must discontinue nonsteroidal anti-inflammatory (NSAIDs) medications 2-5 days prior to and for 1-2 days after receiving Pemetrexed, depending on the half-life of the NSAIDs treatment.",
            "criterions": [
                {
                    "exact_snippets": "Patients must discontinue nonsteroidal anti-inflammatory (NSAIDs) medications",
                    "criterion": "NSAIDs medication",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "2-5 days prior to ... receiving Pemetrexed",
                    "criterion": "NSAIDs medication discontinuation period before Pemetrexed",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "for 1-2 days after receiving Pemetrexed",
                    "criterion": "NSAIDs medication discontinuation period after Pemetrexed",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must agree to this schedule in conjunction with every dose of Pemetrexed.",
            "criterions": [
                {
                    "exact_snippets": "Patients must agree to this schedule",
                    "criterion": "schedule agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must receive 350-1000 mcg of folic acid (e.g. one prenatal vitamin) starting 7 days prior to the first treatment with Pemetrexed.",
            "criterions": [
                {
                    "exact_snippets": "Patients must receive 350-1000 mcg of folic acid",
                    "criterion": "folic acid dosage",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 350,
                                        "unit": "mcg"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1000,
                                        "unit": "mcg"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "starting 7 days prior to the first treatment with Pemetrexed",
                    "criterion": "start time for folic acid",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "7 days prior to first treatment with Pemetrexed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be able to ingest 350-1000 mcg of folic acid daily until 3 weeks after the last dose of Pemetrexed.",
            "criterions": [
                {
                    "exact_snippets": "able to ingest 350-1000 mcg of folic acid daily",
                    "criterion": "folic acid ingestion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 350,
                                        "unit": "mcg"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1000,
                                        "unit": "mcg"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "frequency",
                            "expected_value": "daily"
                        }
                    ]
                },
                {
                    "exact_snippets": "until 3 weeks after the last dose of Pemetrexed",
                    "criterion": "duration of folic acid ingestion",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "until 3 weeks after the last dose of Pemetrexed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must receive 4 mg Dexamethasone by mouth twice daily, 1 day prior to the dose, the day of and the day after every dose of Pemetrexed.",
            "criterions": [
                {
                    "exact_snippets": "Patients must receive 4 mg Dexamethasone by mouth twice daily, 1 day prior to the dose, the day of and the day after every dose of Pemetrexed.",
                    "criterion": "Dexamethasone administration",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": "=",
                                "value": 4,
                                "unit": "mg"
                            }
                        },
                        {
                            "requirement_type": "route",
                            "expected_value": "by mouth"
                        },
                        {
                            "requirement_type": "frequency",
                            "expected_value": "twice daily"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "1 day prior to the dose",
                                "the day of",
                                "the day after every dose of Pemetrexed"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must receive a 1000 mcg vitamin B12 injection 7 days prior to receiving the first treatment with Pemetrexed.",
            "criterions": [
                {
                    "exact_snippets": "Patients must receive a 1000 mcg vitamin B12 injection 7 days prior to receiving the first treatment with Pemetrexed.",
                    "criterion": "vitamin B12 injection",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": "=",
                                "value": 1000,
                                "unit": "mcg"
                            }
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "7 days prior to first treatment with Pemetrexed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must agree to receive 1000 mcg vitamin B12 injection every 9 weeks until 3 weeks after the last dose of Pemetrexed.",
            "criterions": [
                {
                    "exact_snippets": "Patients must agree to receive 1000 mcg vitamin B12 injection every 9 weeks until 3 weeks after the last dose of Pemetrexed.",
                    "criterion": "vitamin B12 injection",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": "=",
                                "value": 1000,
                                "unit": "mcg"
                            }
                        },
                        {
                            "requirement_type": "frequency",
                            "expected_value": "every 9 weeks"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "until 3 weeks after the last dose of Pemetrexed"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients who have had prior therapy with Pemetrexed",
            "criterions": [
                {
                    "exact_snippets": "prior therapy with Pemetrexed",
                    "criterion": "prior therapy with Pemetrexed",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have received radiation to more than 25% of marrow bearing areas",
            "criterions": [
                {
                    "exact_snippets": "received radiation to more than 25% of marrow bearing areas",
                    "criterion": "radiation to marrow bearing areas",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}