{
    "info": {
        "nct_id": "NCT00652691",
        "official_title": "A Dose Seeking Trial of Topotecan Combined With High-Dose Cyclophosphamide and Carboplatin With Peripheral Blood Stem Cell Transplant for the Treatment of Relapsed Ovarian Cancer and Primary Peritoneal Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer\n\n  * Recurrent, relapsed, or persistent disease meeting 1 or more of the following criteria:\n\n    * Patients with a positive second-look laparotomy who are not candidates for higher priority GOG protocols\n    * Largest mass of recurrent disease ≤ 0.2 cm achieved by surgery or chemotherapy\n    * Achievement of complete response to 1 prior regimen of platinum-based chemotherapy with relapse > 6 months from last chemotherapy\n    * Achievement of partial response to 1 platinum-based chemotherapy regimen prior to study\n  * Histological proof of disease recurrence with or without a rising serum CA-125 level (relapsed or recurrent disease)\n* The following histological cell types are allowed:\n\n  * Clear-cell adenocarcinoma\n  * Endometrioid adenocarcinoma\n  * Mixed epithelial carcinoma\n  * Mucinous adenocarcinoma\n  * Serous adenocarcinoma\n  * Undifferentiated carcinoma\n* Must have unilateral bone marrow aspirate and biopsy with cytogenetics without evidence of metastatic ovarian carcinoma by conventional morphology within 1 month of registration\n* Not eligible for GOG-164\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Creatinine ≤ 1.5 mg/dL\n* Total bilirubin ≤ 2.0 mg/dL (≤ 5.0 mg/dL with metastatic disease)\n* AST ≤ 2 times upper limit of normal (ULN) (≤ 600 units/mL with metastatic disease)\n* Alkaline phosphatase ≤ 2 times ULN (unless related to metastatic disease)\n* ANC ≥ 1,000/mm^3\n* Platelets ≥ 100,000/mm^3\n* Cardiac ejection fraction ≥ 45% by rest ECHO or MUGA\n* FEV_1 ≥ 50% of predicted\n* HIV negative\n* No uncontrolled infection\n* No severe medical or psychiatric illness, including any of the following:\n\n  * Renal failure\n  * Brittle insulin dependent diabetes mellitus\n  * Congestive heart failure\n  * History of myocardial infarction within the past 3 months\n  * Significant arrhythmia requiring medication\n  * Poorly controlled hypertension (diastolic blood pressure >100 mm Hg)\n  * History of hospitalization for severe depression or psychosis\n  * Significant non-neoplastic pulmonary disease\n  * Current alcohol or drug abuse.\n  * Active infection\n  * Active peptic ulcer disease\n* No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No more than 1 prior treatment regimen for this cancer\n* More than 3 weeks since surgery\n* No prior topotecan hydrochloride"
    },
    "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 minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "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 ovarian epithelial or primary peritoneal cavity cancer",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed ovarian epithelial ... cancer",
                    "criterion": "ovarian epithelial cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed ... primary peritoneal cavity cancer",
                    "criterion": "primary peritoneal cavity cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recurrent, relapsed, or persistent disease meeting 1 or more of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Recurrent, relapsed, or persistent disease",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "recurrent",
                                "relapsed",
                                "persistent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a positive second-look laparotomy who are not candidates for higher priority GOG protocols",
            "criterions": [
                {
                    "exact_snippets": "Patients with a positive second-look laparotomy",
                    "criterion": "second-look laparotomy",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "who are not candidates for higher priority GOG protocols",
                    "criterion": "candidacy for higher priority GOG protocols",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Largest mass of recurrent disease ≤ 0.2 cm achieved by surgery or chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Largest mass of recurrent disease ≤ 0.2 cm",
                    "criterion": "largest mass of recurrent disease",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 0.2,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "achieved by surgery or chemotherapy",
                    "criterion": "treatment method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "surgery",
                                "chemotherapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Achievement of complete response to 1 prior regimen of platinum-based chemotherapy with relapse > 6 months from last chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Achievement of complete response to 1 prior regimen of platinum-based chemotherapy",
                    "criterion": "response to prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "complete"
                        },
                        {
                            "requirement_type": "regimen_count",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        },
                        {
                            "requirement_type": "chemotherapy_type",
                            "expected_value": "platinum-based"
                        }
                    ]
                },
                {
                    "exact_snippets": "relapse > 6 months from last chemotherapy",
                    "criterion": "relapse time from last chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time_since_last_chemotherapy",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Achievement of partial response to 1 platinum-based chemotherapy regimen prior to study",
            "criterions": [
                {
                    "exact_snippets": "Achievement of partial response to 1 platinum-based chemotherapy regimen",
                    "criterion": "response to platinum-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "partial response"
                        },
                        {
                            "requirement_type": "regimen count",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histological proof of disease recurrence with or without a rising serum CA-125 level (relapsed or recurrent disease)",
            "criterions": [
                {
                    "exact_snippets": "Histological proof of disease recurrence",
                    "criterion": "disease recurrence",
                    "requirements": [
                        {
                            "requirement_type": "proof",
                            "expected_value": "histological"
                        }
                    ]
                },
                {
                    "exact_snippets": "rising serum CA-125 level",
                    "criterion": "serum CA-125 level",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "rising"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The following histological cell types are allowed:",
            "criterions": [
                {
                    "exact_snippets": "The following histological cell types are allowed",
                    "criterion": "histological cell types",
                    "requirements": [
                        {
                            "requirement_type": "allowed types",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clear-cell adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Clear-cell adenocarcinoma",
                    "criterion": "clear-cell adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Endometrioid adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Endometrioid adenocarcinoma",
                    "criterion": "endometrioid adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Mixed epithelial carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Mixed epithelial carcinoma",
                    "criterion": "mixed epithelial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Mucinous adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Mucinous adenocarcinoma",
                    "criterion": "mucinous adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serous adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Serous adenocarcinoma",
                    "criterion": "serous adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Undifferentiated carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Undifferentiated carcinoma",
                    "criterion": "undifferentiated carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have unilateral bone marrow aspirate and biopsy with cytogenetics without evidence of metastatic ovarian carcinoma by conventional morphology within 1 month of registration",
            "criterions": [
                {
                    "exact_snippets": "Must have unilateral bone marrow aspirate and biopsy",
                    "criterion": "bone marrow aspirate and biopsy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cytogenetics without evidence of metastatic ovarian carcinoma by conventional morphology",
                    "criterion": "metastatic ovarian carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 1 month of registration",
                    "criterion": "time since procedure",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not eligible for GOG-164",
            "criterions": [
                {
                    "exact_snippets": "Not eligible for GOG-164",
                    "criterion": "GOG-164 eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine ≤ 1.5 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Creatinine ≤ 1.5 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin ≤ 2.0 mg/dL (≤ 5.0 mg/dL with metastatic disease)",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤ 2.0 mg/dL",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin ... ≤ 5.0 mg/dL with metastatic disease",
                    "criterion": "total bilirubin with metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST ≤ 2 times upper limit of normal (ULN) (≤ 600 units/mL with metastatic disease)",
            "criterions": [
                {
                    "exact_snippets": "AST ≤ 2 times upper limit of normal (ULN)",
                    "criterion": "AST level",
                    "requirements": [
                        {
                            "requirement_type": "comparison to ULN",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST ... ≤ 600 units/mL with metastatic disease",
                    "criterion": "AST level",
                    "requirements": [
                        {
                            "requirement_type": "comparison with metastatic disease",
                            "expected_value": {
                                "operator": "<=",
                                "value": 600,
                                "unit": "units/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline phosphatase ≤ 2 times ULN (unless related to metastatic disease)",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase ≤ 2 times ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ANC ≥ 1,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "ANC ≥ 1,000/mm^3",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥ 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥ 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiac ejection fraction ≥ 45% by rest ECHO or MUGA",
            "criterions": [
                {
                    "exact_snippets": "Cardiac ejection fraction ≥ 45%",
                    "criterion": "cardiac ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* FEV_1 ≥ 50% of predicted",
            "criterions": [
                {
                    "exact_snippets": "FEV_1 ≥ 50% of predicted",
                    "criterion": "FEV_1",
                    "requirements": [
                        {
                            "requirement_type": "percentage of predicted",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HIV negative",
            "criterions": [
                {
                    "exact_snippets": "HIV negative",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncontrolled infection",
            "criterions": [
                {
                    "exact_snippets": "No uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No severe medical or psychiatric illness, including any of the following:",
            "criterions": [
                {
                    "exact_snippets": "severe medical or psychiatric illness",
                    "criterion": "medical or psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Renal failure",
            "criterions": [
                {
                    "exact_snippets": "Renal failure",
                    "criterion": "renal failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Brittle insulin dependent diabetes mellitus",
            "criterions": [
                {
                    "exact_snippets": "Brittle insulin dependent diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "brittle insulin dependent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "Congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of myocardial infarction within the past 3 months",
            "criterions": [
                {
                    "exact_snippets": "History of myocardial infarction within the past 3 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant arrhythmia requiring medication",
            "criterions": [
                {
                    "exact_snippets": "Significant arrhythmia requiring medication",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "medication"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Poorly controlled hypertension (diastolic blood pressure >100 mm Hg)",
            "criterions": [
                {
                    "exact_snippets": "Poorly controlled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic blood pressure >100 mm Hg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of hospitalization for severe depression or psychosis",
            "criterions": [
                {
                    "exact_snippets": "History of hospitalization for severe depression",
                    "criterion": "hospitalization for severe depression",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of hospitalization for ... psychosis",
                    "criterion": "hospitalization for psychosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant non-neoplastic pulmonary disease",
            "criterions": [
                {
                    "exact_snippets": "Significant non-neoplastic pulmonary disease",
                    "criterion": "non-neoplastic pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current alcohol or drug abuse.",
            "criterions": [
                {
                    "exact_snippets": "Current alcohol ... abuse",
                    "criterion": "alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Current ... drug abuse",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection",
            "criterions": [
                {
                    "exact_snippets": "Active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active peptic ulcer disease",
            "criterions": [
                {
                    "exact_snippets": "Active peptic ulcer disease",
                    "criterion": "peptic ulcer disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma",
            "criterions": [
                {
                    "exact_snippets": "No prior malignancy within the past 5 years",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except adequately treated basal cell or squamous cell carcinoma of the skin",
                    "criterion": "basal cell or squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment adequacy",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... in situ cervical carcinoma",
                    "criterion": "in situ cervical carcinoma",
                    "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": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "see referenced section"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No more than 1 prior treatment regimen for this cancer",
            "criterions": [
                {
                    "exact_snippets": "No more than 1 prior treatment regimen for this cancer",
                    "criterion": "prior treatment regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 3 weeks since surgery",
            "criterions": [
                {
                    "exact_snippets": "More than 3 weeks since surgery",
                    "criterion": "time since surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior topotecan hydrochloride",
            "criterions": [
                {
                    "exact_snippets": "No prior topotecan hydrochloride",
                    "criterion": "prior topotecan hydrochloride",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        }
    ]
}