{
    "info": {
        "nct_id": "NCT00322920",
        "official_title": "A Phase I Study of Weekly Topotecan With Cisplatin for the Management of Advanced Stage or Recurrent Carcinoma of the Cervix",
        "inclusion_criteria": "* Patients must have persistent, recurrent, or primary Stage IVB carcinoma of the cervix not amenable to curative therapy with either surgery and/or radiation.\n* Patients must have biopsy proven squamous cell, adenosquamous, or adenocarcinoma histology.\n* Patients do not require measurable disease.\n* Patients must have adequate organ function defined by laboratory work.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Patients must have recovered from any effects attributable to surgery, radiation, or chemoradiotherapy. A minimum of six weeks shall have passed since the last administration of chemoradiotherapy or three weeks for radiation therapy alone.\n* Patients must be free of clinically significant infections.\n* Patients must be age 19 or greater and have signed informed consent.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 19 Years",
        "exclusion_criteria": "* Patients who are pregnant or lactating.\n* Patients with history of other malignancies (except non-melanoma skin cancer) within the last 5 years are ineligible.\n* Patients with non-squamous, adenosquamous, or adenocarcinoma histology.\n* Patients with bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage.\n* Patients currently receiving any or having received other investigational agents within the last 30 days are ineligible.\n* Patients with known hypersensitivity to topotecan or cisplatin.\n* Patients with craniospinal metastases.\n* Patients with uncontrolled current illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, serious peripheral neuropathy, or psychiatric illness/social situations that would limit or preclude compliance with study requirements are ineligible.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must have persistent, recurrent, or primary Stage IVB carcinoma of the cervix not amenable to curative therapy with either surgery and/or radiation.",
            "criterions": [
                {
                    "exact_snippets": "persistent, recurrent, or primary Stage IVB carcinoma of the cervix",
                    "criterion": "carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IVB"
                        },
                        {
                            "requirement_type": "persistence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "primary",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not amenable to curative therapy with either surgery and/or radiation",
                    "criterion": "amenability to curative therapy",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have biopsy proven squamous cell, adenosquamous, or adenocarcinoma histology.",
            "criterions": [
                {
                    "exact_snippets": "biopsy proven squamous cell",
                    "criterion": "squamous cell histology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "biopsy proven ... adenosquamous",
                    "criterion": "adenosquamous histology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "biopsy proven ... adenocarcinoma histology",
                    "criterion": "adenocarcinoma histology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients do not require measurable disease.",
            "criterions": [
                {
                    "exact_snippets": "do not require measurable disease",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have adequate organ function defined by laboratory work.",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have recovered from any effects attributable to surgery, radiation, or chemoradiotherapy. A minimum of six weeks shall have passed since the last administration of chemoradiotherapy or three weeks for radiation therapy alone.",
            "criterions": [
                {
                    "exact_snippets": "Patients must have recovered from any effects attributable to surgery, radiation, or chemoradiotherapy.",
                    "criterion": "recovery from treatment effects",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "A minimum of six weeks shall have passed since the last administration of chemoradiotherapy",
                    "criterion": "time since last chemoradiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "three weeks for radiation therapy alone",
                    "criterion": "time since last radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be free of clinically significant infections.",
            "criterions": [
                {
                    "exact_snippets": "free of clinically significant infections",
                    "criterion": "clinically significant infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be age 19 or greater and have signed informed consent.",
            "criterions": [
                {
                    "exact_snippets": "age 19 or greater",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "healthy volunteers",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 19 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 19 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients who are pregnant or lactating.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with history of other malignancies (except non-melanoma skin cancer) within the last 5 years are ineligible.",
            "criterions": [
                {
                    "exact_snippets": "history of other malignancies (except non-melanoma skin cancer) within the last 5 years",
                    "criterion": "history of other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with non-squamous, adenosquamous, or adenocarcinoma histology.",
            "criterions": [
                {
                    "exact_snippets": "non-squamous",
                    "criterion": "histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-squamous"
                        }
                    ]
                },
                {
                    "exact_snippets": "adenosquamous",
                    "criterion": "histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "adenosquamous"
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma",
                    "criterion": "histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "adenocarcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage.",
            "criterions": [
                {
                    "exact_snippets": "bilateral hydronephrosis",
                    "criterion": "bilateral hydronephrosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot be alleviated by ureteral stents",
                    "criterion": "alleviation by ureteral stents",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot be alleviated by ... percutaneous drainage",
                    "criterion": "alleviation by percutaneous drainage",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients currently receiving any or having received other investigational agents within the last 30 days are ineligible.",
            "criterions": [
                {
                    "exact_snippets": "Patients currently receiving any or having received other investigational agents within the last 30 days",
                    "criterion": "investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with known hypersensitivity to topotecan or cisplatin.",
            "criterions": [
                {
                    "exact_snippets": "known hypersensitivity to topotecan",
                    "criterion": "hypersensitivity to topotecan",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known hypersensitivity to ... cisplatin",
                    "criterion": "hypersensitivity to cisplatin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with craniospinal metastases.",
            "criterions": [
                {
                    "exact_snippets": "craniospinal metastases",
                    "criterion": "craniospinal metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with uncontrolled current illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, serious peripheral neuropathy, or psychiatric illness/social situations that would limit or preclude compliance with study requirements are ineligible.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled current illness ... ongoing or active infection",
                    "criterion": "ongoing or active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled current illness ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled current illness ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled current illness ... serious peripheral neuropathy",
                    "criterion": "serious peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled current illness ... psychiatric illness/social situations that would limit or preclude compliance with study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "limit or preclude"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}