{
    "info": {
        "nct_id": "NCT00061308",
        "official_title": "An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer",
        "inclusion_criteria": "* Have had one prior platinum-based chemotherapy regimen for the treatment of primary disease.\n* At least 4 weeks since last surgery or radiation therapy.\n* Must have had a treatment-free interval of greater than 6 months following response to platinum.\n* ECOG performance status of 0,1, or 2.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Women of child-bearing potential that do not practice adequate contraception.\n* Pregnant or lactating.\n* Received more than one primary chemotherapy regimen.\n* Concomitant or previous malignancies with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer from which the patient has been disease free for 5 years.\n* Active uncontrolled infection requiring antibiotics.\n* Concurrent severe medical problems unrelated to the malignancy which would limit full compliance with the study.\n* Received radiation to more than 10% of bone.\n* Prior treatment with topotecan or gemcitabine.\n* Hypersensitivity to camptothecin or nucleoside analogues.\n* Use of an investigational agent within 30 days.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Have had one prior platinum-based chemotherapy regimen for the treatment of primary disease.",
            "criterions": [
                {
                    "exact_snippets": [
                        "one prior platinum-based chemotherapy regimen"
                    ],
                    "criterion": "platinum-based chemotherapy regimen",
                    "requirement_type": "quantity",
                    "expected_value": ">= 1"
                },
                {
                    "exact_snippets": [
                        "treatment of primary disease"
                    ],
                    "criterion": "primary disease",
                    "requirement_type": "treatment",
                    "expected_value": "platinum-based chemotherapy"
                }
            ]
        },
        {
            "line": "* At least 4 weeks since last surgery or radiation therapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "4 weeks since last surgery"
                    ],
                    "criterion": "time since last surgery",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 4
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "4 weeks since last",
                        "radiation therapy"
                    ],
                    "criterion": "time since last radiation therapy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 4
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Must have had a treatment-free interval of greater than 6 months following response to platinum.",
            "criterions": [
                {
                    "exact_snippets": [
                        "treatment-free interval of greater than 6 months"
                    ],
                    "criterion": "treatment-free interval",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 6
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "response to platinum"
                    ],
                    "criterion": "response to platinum",
                    "requirement_type": "response",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* ECOG performance status of 0,1, or 2.",
            "criterions": [
                {
                    "exact_snippets": [
                        "ECOG performance status of 0,1, or 2"
                    ],
                    "criterion": "ECOG performance status",
                    "requirement_type": "value",
                    "expected_value": [
                        "0",
                        "1",
                        "2"
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "volunteer health status",
                    "requirement_type": "allowance",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": [
                        "Must be FEMALE"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specific value",
                    "expected_value": "female"
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Women of child-bearing potential that do not practice adequate contraception.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Women of child-bearing potential"
                    ],
                    "criterion": "child-bearing potential",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "do not practice adequate contraception"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "adequacy",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Pregnant or lactating.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "lactating"
                    ],
                    "criterion": "lactation",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Received more than one primary chemotherapy regimen.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Received more than one primary chemotherapy regimen"
                    ],
                    "criterion": "primary chemotherapy regimen",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "operator": ">",
                        "value": 1
                    }
                }
            ]
        },
        {
            "line": "* Concomitant or previous malignancies with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer from which the patient has been disease free for 5 years.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Concomitant or previous malignancies"
                    ],
                    "criterion": "malignancies",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "adequately treated basal cell or squamous cell skin cancer"
                    ],
                    "criterion": "basal cell or squamous cell skin cancer",
                    "requirement_type": "treatment status",
                    "expected_value": "adequately treated"
                },
                {
                    "exact_snippets": [
                        "in situ cervical cancer"
                    ],
                    "criterion": "cervical cancer",
                    "requirement_type": "stage",
                    "expected_value": "in situ"
                },
                {
                    "exact_snippets": [
                        "incidental carcinoid"
                    ],
                    "criterion": "carcinoid",
                    "requirement_type": "incidental",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "other cancer from which the patient has been disease free for 5 years"
                    ],
                    "criterion": "other cancer",
                    "requirement_type": "disease-free duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Active uncontrolled infection requiring antibiotics.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Active uncontrolled infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "control status",
                    "expected_value": "uncontrolled"
                },
                {
                    "exact_snippets": [
                        "requiring antibiotics"
                    ],
                    "criterion": "infection",
                    "requirement_type": "treatment requirement",
                    "expected_value": "antibiotics"
                }
            ]
        },
        {
            "line": "* Concurrent severe medical problems unrelated to the malignancy which would limit full compliance with the study.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Concurrent severe medical problems unrelated to the malignancy"
                    ],
                    "criterion": "severe medical problems",
                    "requirement_type": "concurrency",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Concurrent severe medical problems unrelated to the malignancy which would limit full compliance with the study"
                    ],
                    "criterion": "compliance with the study",
                    "requirement_type": "limitation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Received radiation to more than 10% of bone.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Received radiation",
                        "more than 10% of bone"
                    ],
                    "criterion": "bone radiation",
                    "requirement_type": "extent",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 10
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Hypersensitivity to camptothecin or nucleoside analogues.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Hypersensitivity to camptothecin"
                    ],
                    "criterion": "camptothecin",
                    "requirement_type": "hypersensitivity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Hypersensitivity to",
                        "nucleoside analogues"
                    ],
                    "criterion": "nucleoside analogues",
                    "requirement_type": "hypersensitivity",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Use of an investigational agent within 30 days.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Use of an investigational agent"
                    ],
                    "criterion": "investigational agent",
                    "requirement_type": "use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "within 30 days"
                    ],
                    "criterion": "time since last investigational agent use",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 30
                            }
                        ]
                    }
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Prior treatment with topotecan or gemcitabine.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Prior treatment with topotecan"
                    ],
                    "criterion": "topotecan",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Prior treatment with gemcitabine"
                    ],
                    "criterion": "gemcitabine",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}