{
    "info": {
        "nct_id": "NCT00127920",
        "official_title": "A Phase II, Open-Label, Non-Randomized, Multi-Center Pilot Study of Intravenous Taxol, Carboplatin, Bevacizumab Given Every 21 Days in Patients With Newly Diagnosed Stage III/IV Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer",
        "inclusion_criteria": "* Subjects with a histologic or cytologic diagnosis of stage III/IV ovarian cancer, fallopian tube epithelial cancer, or peritoneal cancer who have not received prior chemotherapy or radiotherapy.\n* Subjects must have the appropriate surgery for their gynecologic cancer. However, subjects may be treated in a neoadjuvant manner, with surgery being performed after chemotherapy cycles 1, 2, or 3.\n* If neoadjuvant therapy is not administered, subjects must receive their first dose no more than six weeks postoperatively.\n* Subjects must have adequate bone marrow, renal and hepatic function as defined by WBC > 3,000 cells/cu ml., platelets > 100,000/cu.ml., calculated creatinine clearance > 50 ccs/min., bilirubin < 1.5 mg/dl, and SGOT < three times normal.\n* Karnofsky performance status > 50%.\n* Subjects who have signed an institutional review board (IRB) approved informed consent form.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Subjects with epithelial ovarian cancer of low malignancy potential.\n* Subjects with septicemia, severe infection, or acute hepatitis.\n* Subjects with severe gastrointestinal bleeding.\n* Subjects with a history of congestive heart failure, angina, or a history of myocardial infarction within the past six months.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Subjects with a histologic or cytologic diagnosis of stage III/IV ovarian cancer, fallopian tube epithelial cancer, or peritoneal cancer who have not received prior chemotherapy or radiotherapy.",
            "criterions": [
                {
                    "exact_snippets": "histologic or cytologic diagnosis",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologic",
                                "cytologic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "stage III/IV ovarian cancer",
                    "criterion": "ovarian cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "fallopian tube epithelial cancer",
                    "criterion": "fallopian tube epithelial cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "peritoneal cancer",
                    "criterion": "peritoneal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "have not received prior chemotherapy or radiotherapy",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must have the appropriate surgery for their gynecologic cancer. However, subjects may be treated in a neoadjuvant manner, with surgery being performed after chemotherapy cycles 1, 2, or 3.",
            "criterions": [
                {
                    "exact_snippets": "appropriate surgery for their gynecologic cancer",
                    "criterion": "surgery for gynecologic cancer",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated in a neoadjuvant manner",
                    "criterion": "neoadjuvant treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "neoadjuvant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If neoadjuvant therapy is not administered, subjects must receive their first dose no more than six weeks postoperatively.",
            "criterions": [
                {
                    "exact_snippets": "neoadjuvant therapy is not administered",
                    "criterion": "neoadjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "receive their first dose no more than six weeks postoperatively",
                    "criterion": "first dose timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks postoperatively"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky performance status > 50%.",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky performance status > 50%",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects who have signed an institutional review board (IRB) approved informed consent form.",
            "criterions": [
                {
                    "exact_snippets": "signed an institutional review board (IRB) approved informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": "IRB approved"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "signed"
                        }
                    ]
                }
            ]
        },
        {
            "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": [
        {
            "line": "* Subjects with epithelial ovarian cancer of low malignancy potential.",
            "criterions": [
                {
                    "exact_snippets": "epithelial ovarian cancer",
                    "criterion": "epithelial ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "low malignancy potential",
                    "criterion": "malignancy potential",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "low"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with septicemia, severe infection, or acute hepatitis.",
            "criterions": [
                {
                    "exact_snippets": "Subjects with septicemia",
                    "criterion": "septicemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe infection",
                    "criterion": "severe infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "acute hepatitis",
                    "criterion": "acute hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with severe gastrointestinal bleeding.",
            "criterions": [
                {
                    "exact_snippets": "severe gastrointestinal bleeding",
                    "criterion": "gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with a history of congestive heart failure, angina, or a history of myocardial infarction within the past six months.",
            "criterions": [
                {
                    "exact_snippets": "history of congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of myocardial infarction within the past six months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past six months"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Subjects must have adequate bone marrow, renal and hepatic function as defined by WBC > 3,000 cells/cu ml., platelets > 100,000/cu.ml., calculated creatinine clearance > 50 ccs/min., bilirubin < 1.5 mg/dl, and SGOT < three times normal.",
            "criterions": [
                {
                    "exact_snippets": "adequate bone marrow ... WBC > 3,000 cells/cu ml.",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "WBC count",
                            "expected_value": {
                                "operator": ">",
                                "value": 3000,
                                "unit": "cells/cu ml"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... renal function ... calculated creatinine clearance > 50 ccs/min.",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "creatinine clearance",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "ccs/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... hepatic function ... bilirubin < 1.5 mg/dl, and SGOT < three times normal.",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "bilirubin level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "mg/dl"
                            }
                        },
                        {
                            "requirement_type": "SGOT level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "times normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets > 100,000/cu.ml.",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "cu.ml"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}