{
    "info": {
        "nct_id": "NCT00045682",
        "official_title": "A Phase II Evaluation of CT-2103 in the Third-Line Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Cancer",
        "inclusion_criteria": "* Histologically confirmed recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer after second-line therapy\n\n  * Received 1 prior platinum-based first-line chemotherapy regimen and 1 prior second-line (non-platinum, non-taxane) chemotherapy regimen\n* At least 1 unidimensionally measurable lesion\n\n  * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan\n  * At least 1 target lesion that has not previously been irradiated\n* Ineligible for a higher priority GOG protocol (if one exists)\n* Ineligible for the currently active phase II cytotoxic protocol for platinum-resistant disease\n* Performance status - GOG 0-2\n* Absolute neutrophil count at least 1,500/mm^3\n* Platelet count at least 100,000/mm^3\n* No active bleeding\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* SGOT no greater than 2.5 times ULN\n* Alkaline phosphatase no greater than 2.5 times ULN\n* PT or PTT less than ULN\n* Creatinine no greater than 1.5 times ULN\n* No uncontrolled hypertension\n* No uncompensated congestive heart failure\n* No symptomatic coronary artery disease\n* No myocardial infarction within the past 6 months\n* No sensory or motor neuropathy greater than grade 1\n* No active infection requiring antibiotics\n* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* At least 3 weeks since prior biological therapy or immunotherapy directed at the malignancy\n* No prior polyglutamate paclitaxel (CT-2103)\n* Recovered from prior chemotherapy\n* At least 1 week since prior hormonal therapy directed at the malignancy\n* Concurrent hormone replacement therapy allowed\n* Recovered from prior radiotherapy\n* No prior radiotherapy to more than 25% of bone marrow\n* Recovered from prior surgery\n* At least 3 weeks since other prior therapy directed at the malignancy\n* No prior therapy for another malignancy that would preclude this study\n* No concurrent amifostine or other protective reagents\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer after second-line therapy",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed recurrent or persistent ovarian epithelial cancer",
                    "criterion": "ovarian epithelial cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "recurrent",
                                "persistent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "primary peritoneal cancer",
                    "criterion": "primary peritoneal cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "after second-line therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received 1 prior platinum-based first-line chemotherapy regimen and 1 prior second-line (non-platinum, non-taxane) chemotherapy regimen",
            "criterions": [
                {
                    "exact_snippets": "Received 1 prior platinum-based first-line chemotherapy regimen",
                    "criterion": "prior platinum-based first-line chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "1 prior second-line (non-platinum, non-taxane) chemotherapy regimen",
                    "criterion": "prior second-line chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "platinum",
                                "taxane"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 1 unidimensionally measurable lesion",
            "criterions": [
                {
                    "exact_snippets": "At least 1 unidimensionally measurable lesion",
                    "criterion": "unidimensionally measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan",
            "criterions": [
                {
                    "exact_snippets": "At least 20 mm by conventional techniques",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "mm"
                            }
                        },
                        {
                            "requirement_type": "measurement method",
                            "expected_value": "conventional techniques"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 10 mm by spiral CT scan",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        },
                        {
                            "requirement_type": "measurement method",
                            "expected_value": "spiral CT scan"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 1 target lesion that has not previously been irradiated",
            "criterions": [
                {
                    "exact_snippets": "At least 1 target lesion",
                    "criterion": "target lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lesion that has not previously been irradiated",
                    "criterion": "lesion irradiation history",
                    "requirements": [
                        {
                            "requirement_type": "irradiation status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ineligible for a higher priority GOG protocol (if one exists)",
            "criterions": [
                {
                    "exact_snippets": "Ineligible for a higher priority GOG protocol",
                    "criterion": "eligibility for higher priority GOG protocol",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ineligible for the currently active phase II cytotoxic protocol for platinum-resistant disease",
            "criterions": [
                {
                    "exact_snippets": "Ineligible for the currently active phase II cytotoxic protocol",
                    "criterion": "eligibility for phase II cytotoxic protocol",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "platinum-resistant disease",
                    "criterion": "platinum-resistant disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status - GOG 0-2",
            "criterions": [
                {
                    "exact_snippets": "Performance status - GOG 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "GOG"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "GOG"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Platelet count at least 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count at least 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active bleeding",
            "criterions": [
                {
                    "exact_snippets": "No active bleeding",
                    "criterion": "active bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin no greater than 1.5 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin no greater than 1.5 times upper limit of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* SGOT no greater than 2.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "SGOT no greater than 2.5 times ULN",
                    "criterion": "SGOT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline phosphatase no greater than 2.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase no greater than 2.5 times ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PT or PTT less than ULN",
            "criterions": [
                {
                    "exact_snippets": "PT or PTT less than ULN",
                    "criterion": "PT or PTT",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine no greater than 1.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Creatinine no greater than 1.5 times ULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncontrolled hypertension",
            "criterions": [
                {
                    "exact_snippets": "No uncontrolled hypertension",
                    "criterion": "uncontrolled hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncompensated congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "No uncompensated congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "compensation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No symptomatic coronary artery disease",
            "criterions": [
                {
                    "exact_snippets": "No symptomatic coronary artery disease",
                    "criterion": "symptomatic coronary artery disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No myocardial infarction within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "No myocardial infarction within the past 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since last event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No sensory or motor neuropathy greater than grade 1",
            "criterions": [
                {
                    "exact_snippets": "No sensory or motor neuropathy greater than grade 1",
                    "criterion": "sensory neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No sensory or motor neuropathy greater than grade 1",
                    "criterion": "motor neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active infection requiring antibiotics",
            "criterions": [
                {
                    "exact_snippets": "No active infection requiring antibiotics",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer",
            "criterions": [
                {
                    "exact_snippets": "No other invasive malignancy within the past 5 years",
                    "criterion": "invasive malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "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": "* Negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* At least 3 weeks since prior biological therapy or immunotherapy directed at the malignancy",
            "criterions": [
                {
                    "exact_snippets": "At least 3 weeks since prior biological therapy",
                    "criterion": "biological therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since prior treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 3 weeks since prior ... immunotherapy directed at the malignancy",
                    "criterion": "immunotherapy directed at the malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time since prior treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior polyglutamate paclitaxel (CT-2103)",
            "criterions": [
                {
                    "exact_snippets": "No prior polyglutamate paclitaxel (CT-2103)",
                    "criterion": "prior polyglutamate paclitaxel (CT-2103)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recovered from prior chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Recovered from prior chemotherapy",
                    "criterion": "recovery from prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 1 week since prior hormonal therapy directed at the malignancy",
            "criterions": [
                {
                    "exact_snippets": "At least 1 week since prior hormonal therapy directed at the malignancy",
                    "criterion": "time since prior hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent hormone replacement therapy allowed",
            "criterions": [
                {
                    "exact_snippets": "Concurrent hormone replacement therapy allowed",
                    "criterion": "hormone replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recovered from prior radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Recovered from prior radiotherapy",
                    "criterion": "recovery from prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior radiotherapy to more than 25% of bone marrow",
            "criterions": [
                {
                    "exact_snippets": "No prior radiotherapy to more than 25% of bone marrow",
                    "criterion": "prior radiotherapy to bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": "<=",
                                "value": 25,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recovered from prior surgery",
            "criterions": [
                {
                    "exact_snippets": "Recovered from prior surgery",
                    "criterion": "recovery from prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 3 weeks since other prior therapy directed at the malignancy",
            "criterions": [
                {
                    "exact_snippets": "At least 3 weeks since other prior therapy directed at the malignancy",
                    "criterion": "time since prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior therapy for another malignancy that would preclude this study",
            "criterions": [
                {
                    "exact_snippets": "No prior therapy for another malignancy",
                    "criterion": "prior therapy for another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "that would preclude this study",
                    "criterion": "preclusion from study",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "prior therapy for another malignancy"
                        }
                    ]
                }
            ]
        },
        {
            "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": "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}