{
    "info": {
        "nct_id": "NCT00006482",
        "official_title": "A Phase II Evaluation Of Gemcitabine And Cisplatin In Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed refractory or recurrent squamous cell carcinoma of the cervix that has failed local therapy and is considered incurable\n* Must have had 1 prior chemotherapy regimen for cervical cancer\n\n  * No more than 1 prior chemotherapy regimen (single or combination drug therapy), unless used as a radiosensitizer\n  * No prior chemotherapy for recurrent or persistent disease including retreatment with initial chemotherapy\n* Bidimensionally measurable disease\n* Ineligible for higher priority GOG protocol\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Not specified\n\nPerformance status:\n\n* GOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Platelet count at least lower limit of normal\n* Absolute neutrophil count at least 1,500/mm^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times normal\n* SGOT and alkaline phosphatase no greater than 3 times normal\n\nRenal:\n\n* Creatinine no greater than 2.0 mg/dL\n\nOther:\n\n* Not pregnant\n* Fertile patients must use effective contraception\n* No significant infection\n* No other malignancies within past 5 years except nonmelanoma skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 3 weeks since prior biologic therapy for cervical cancer\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 3 weeks since prior chemotherapy for cervical cancer and recovered\n* No prior gemcitabine\n\nEndocrine therapy:\n\n* At least 3 weeks since prior endocrine therapy for cervical cancer\n\nRadiotherapy:\n\n* At least 3 weeks since prior radiotherapy for cervical cancer and recovered\n* No prior radiotherapy to more than 25% of marrow-bearing areas\n\nSurgery:\n\n* At least 3 weeks since prior surgery for cervical cancer and recovered\n\nOther:\n\n* No concurrent amifostine or other protective reagents\n* No prior anticancer therapy that contraindicates study"
    },
    "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": "FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed refractory or recurrent squamous cell carcinoma of the cervix that has failed local therapy and is considered incurable",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed",
                    "criterion": "histological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory or recurrent squamous cell carcinoma of the cervix",
                    "criterion": "squamous cell carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "refractory",
                                "recurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "failed local therapy",
                    "criterion": "local therapy",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": "failed"
                        }
                    ]
                },
                {
                    "exact_snippets": "considered incurable",
                    "criterion": "curability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "incurable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have had 1 prior chemotherapy regimen for cervical cancer",
            "criterions": [
                {
                    "exact_snippets": "Must have had 1 prior chemotherapy regimen for cervical cancer",
                    "criterion": "prior chemotherapy regimen for cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No more than 1 prior chemotherapy regimen (single or combination drug therapy), unless used as a radiosensitizer",
            "criterions": [
                {
                    "exact_snippets": "No more than 1 prior chemotherapy regimen",
                    "criterion": "prior chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless used as a radiosensitizer",
                    "criterion": "use of chemotherapy regimen as a radiosensitizer",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior chemotherapy for recurrent or persistent disease including retreatment with initial chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy for recurrent or persistent disease",
                    "criterion": "prior chemotherapy for recurrent or persistent disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "including retreatment with initial chemotherapy",
                    "criterion": "retreatment with initial chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bidimensionally measurable disease",
            "criterions": [
                {
                    "exact_snippets": "Bidimensionally measurable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "bidimensional"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ineligible for higher priority GOG protocol",
            "criterions": [
                {
                    "exact_snippets": "Ineligible for higher priority GOG protocol",
                    "criterion": "GOG protocol eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age:",
            "criterions": [
                {
                    "exact_snippets": "Age:",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Performance status:",
            "criterions": [
                {
                    "exact_snippets": "Performance status:",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* GOG 0-2",
            "criterions": [
                {
                    "exact_snippets": "GOG 0-2",
                    "criterion": "GOG 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": "* Platelet count at least lower limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Platelet count at least lower limit of normal",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": ">= lower limit of normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count at least 1,500/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count at least 1,500/mm^3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic:",
            "criterions": [
                {
                    "exact_snippets": "Hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin no greater than 1.5 times normal",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin no greater than 1.5 times normal",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* SGOT and alkaline phosphatase no greater than 3 times normal",
            "criterions": [
                {
                    "exact_snippets": "SGOT ... no greater than 3 times normal",
                    "criterion": "SGOT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase no greater than 3 times normal",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal:",
            "criterions": [
                {
                    "exact_snippets": "Renal:",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine no greater than 2.0 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Creatinine no greater than 2.0 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* No significant infection",
            "criterions": [
                {
                    "exact_snippets": "No significant infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other malignancies within past 5 years except nonmelanoma skin cancer",
            "criterions": [
                {
                    "exact_snippets": "No other malignancies within past 5 years",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except nonmelanoma skin cancer",
                    "criterion": "nonmelanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* At least 3 weeks since prior biologic therapy for cervical cancer",
            "criterions": [
                {
                    "exact_snippets": "At least 3 weeks since prior biologic therapy for cervical cancer",
                    "criterion": "time since prior biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 3 weeks since prior chemotherapy for cervical cancer and recovered",
            "criterions": [
                {
                    "exact_snippets": "At least 3 weeks since prior chemotherapy for cervical cancer",
                    "criterion": "time since prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior gemcitabine",
            "criterions": [
                {
                    "exact_snippets": "No prior gemcitabine",
                    "criterion": "gemcitabine treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Endocrine therapy:",
            "criterions": [
                {
                    "exact_snippets": "Endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 3 weeks since prior endocrine therapy for cervical cancer",
            "criterions": [
                {
                    "exact_snippets": "At least 3 weeks since prior endocrine therapy for cervical cancer",
                    "criterion": "endocrine therapy for cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "time since prior therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Radiotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 3 weeks since prior radiotherapy for cervical cancer and recovered",
            "criterions": [
                {
                    "exact_snippets": "At least 3 weeks since prior radiotherapy for cervical cancer",
                    "criterion": "time since prior radiotherapy for cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior radiotherapy to more than 25% of marrow-bearing areas",
            "criterions": [
                {
                    "exact_snippets": "No prior radiotherapy to more than 25% of marrow-bearing areas",
                    "criterion": "prior radiotherapy to marrow-bearing areas",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": "<=",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery:",
            "criterions": [
                {
                    "exact_snippets": "Surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 3 weeks since prior surgery for cervical cancer and recovered",
            "criterions": [
                {
                    "exact_snippets": "At least 3 weeks since prior surgery for cervical cancer",
                    "criterion": "time since prior surgery for cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent amifostine or other protective reagents",
            "criterions": [
                {
                    "exact_snippets": "No concurrent amifostine",
                    "criterion": "amifostine",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent ... other protective reagents",
                    "criterion": "protective reagents",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior anticancer therapy that contraindicates study",
            "criterions": [
                {
                    "exact_snippets": "No prior anticancer therapy that contraindicates study",
                    "criterion": "prior anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other:",
            "criterions": []
        },
        {
            "line": "Other:",
            "criterions": []
        }
    ]
}