{
    "info": {
        "nct_id": "NCT00050349",
        "official_title": "EPO906 Therapy in Patients With Metastatic Carcinoid Tumors and Other Neuroendocrine Tumors",
        "inclusion_criteria": "* Patients with biopsy-proven metastatic carcinoid tumors or other neuroendocrine tumors (Islet cell, Gastrinomas and VIPomas) with at least one measurable lesion (other than bone) that has either not been previously irradiated or if previously irradiated has demonstrated progression since the radiation therapy\n* The patient has no major impairment of renal or hepatic function, as defined by the following laboratory parameters: total bilirubin <1.5 X ULN; AST, ALT<2.5X ULN (<5 X ULN if liver metastases are present)\n* Patients on Sandostatin Lar (long acting somatostatin analogue) must be on a stable dose for 30 days prior to study entry and short acting somatostatin analogues must be judged to be on a clinically stable dose by the investigator prior to study entry\n* Must have a life expectancy of greater than three (3) months\n* Karnofsky Performance Status > 60\n* Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal.)\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients with symptomatic CNS metastases or leptomeningeal involvement\n* Patients with known brain metastases, unless these metastases have been treated and/or have been stable for at least six months prior to study start. Subjects with a history of brain metastases must have a head CT with contrast to document either response or progression.\n* Patients with bone metastases as the only site(s) of measurable disease\n* Patients with hepatic artery chemoembolization within the last 6 months (one month if there are other sites of measurable disease)\n* Patients who have been previously treated with radioactive directed therapies\n* Patients who have been previously treated with epothilone\n* Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1\n* Patients with severe cardiac insufficiency patients taking Coumadin or other warfarin-containing agents with the exception of low dose warfarin (1 mg or less) for the maintenance of in-dwelling lines or ports\n* Patients taking any experimental therapies history of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer, prostate cancer, or cervical cancer in situ\n* Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae\n* Patients with a medical or psychiatric illness that would preclude study or informed consent and/or history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits\n* HIV+ patients\n* Pregnant or lactating females.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with biopsy-proven metastatic carcinoid tumors or other neuroendocrine tumors (Islet cell, Gastrinomas and VIPomas) with at least one measurable lesion (other than bone) that has either not been previously irradiated or if previously irradiated has demonstrated progression since the radiation therapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "biopsy-proven metastatic carcinoid tumors"
                    ],
                    "criterion": "metastatic carcinoid tumors",
                    "requirement_type": "confirmation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "biopsy-proven",
                        "other neuroendocrine tumors (Islet cell, Gastrinomas and VIPomas)"
                    ],
                    "criterion": "neuroendocrine tumors",
                    "requirement_type": "confirmation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "at least one measurable lesion"
                    ],
                    "criterion": "measurable lesion",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "other than bone"
                    ],
                    "criterion": "lesion location",
                    "requirement_type": "exclusion",
                    "expected_value": "bone"
                },
                {
                    "exact_snippets": [
                        "not been previously irradiated"
                    ],
                    "criterion": "lesion irradiation history",
                    "requirement_type": "history",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "if previously irradiated has demonstrated progression since the radiation therapy"
                    ],
                    "criterion": "lesion progression post-irradiation",
                    "requirement_type": "progression",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* The patient has no major impairment of renal or hepatic function, as defined by the following laboratory parameters: total bilirubin <1.5 X ULN; AST, ALT<2.5X ULN (<5 X ULN if liver metastases are present)",
            "criterions": [
                {
                    "exact_snippets": [
                        "no major impairment of renal or hepatic function"
                    ],
                    "criterion": "renal function",
                    "requirement_type": "impairment",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "no major impairment of renal or hepatic function"
                    ],
                    "criterion": "hepatic function",
                    "requirement_type": "impairment",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "total bilirubin <1.5 X ULN"
                    ],
                    "criterion": "total bilirubin",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<",
                        "value": 1.5
                    }
                },
                {
                    "exact_snippets": [
                        "AST, ALT<2.5X ULN"
                    ],
                    "criterion": "AST",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<",
                        "value": 2.5
                    }
                },
                {
                    "exact_snippets": [
                        "AST, ALT<2.5X ULN"
                    ],
                    "criterion": "ALT",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<",
                        "value": 2.5
                    }
                },
                {
                    "exact_snippets": [
                        "<5 X ULN if liver metastases are present"
                    ],
                    "criterion": "AST",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<",
                        "value": 5
                    }
                },
                {
                    "exact_snippets": [
                        "<5 X ULN if liver metastases are present"
                    ],
                    "criterion": "ALT",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<",
                        "value": 5
                    }
                },
                {
                    "exact_snippets": [
                        "if liver metastases are present"
                    ],
                    "criterion": "liver metastases",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients on Sandostatin Lar (long acting somatostatin analogue) must be on a stable dose for 30 days prior to study entry and short acting somatostatin analogues must be judged to be on a clinically stable dose by the investigator prior to study entry",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients on Sandostatin Lar",
                        "must be on a stable dose for 30 days prior to study entry"
                    ],
                    "criterion": "Sandostatin Lar",
                    "requirement_type": "dose stability",
                    "expected_value": "stable for 30 days"
                },
                {
                    "exact_snippets": [
                        "short acting somatostatin analogues",
                        "must be judged to be on a clinically stable dose by the investigator prior to study entry"
                    ],
                    "criterion": "short acting somatostatin analogues",
                    "requirement_type": "dose stability",
                    "expected_value": "clinically stable"
                }
            ]
        },
        {
            "line": "* Must have a life expectancy of greater than three (3) months",
            "criterions": [
                {
                    "exact_snippets": [
                        "life expectancy of greater than three (3) months"
                    ],
                    "criterion": "life expectancy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "operator": ">",
                        "value": 3
                    }
                }
            ]
        },
        {
            "line": "* Karnofsky Performance Status > 60",
            "criterions": [
                {
                    "exact_snippets": [
                        "Karnofsky Performance Status > 60"
                    ],
                    "criterion": "Karnofsky Performance Status",
                    "requirement_type": "value",
                    "expected_value": {
                        "operator": ">",
                        "value": 60
                    }
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "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": "* Patients with symptomatic CNS metastases or leptomeningeal involvement",
            "criterions": [
                {
                    "exact_snippets": [
                        "symptomatic CNS metastases"
                    ],
                    "criterion": "CNS metastases",
                    "requirement_type": "symptomatic",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "leptomeningeal involvement"
                    ],
                    "criterion": "leptomeningeal involvement",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients with known brain metastases, unless these metastases have been treated and/or have been stable for at least six months prior to study start. Subjects with a history of brain metastases must have a head CT with contrast to document either response or progression.",
            "criterions": [
                {
                    "exact_snippets": [
                        "known brain metastases"
                    ],
                    "criterion": "brain metastases",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "metastases have been treated"
                    ],
                    "criterion": "brain metastases",
                    "requirement_type": "treatment status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "metastases have been",
                        "stable for at least six months"
                    ],
                    "criterion": "brain metastases",
                    "requirement_type": "stability duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 6
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "history of brain metastases"
                    ],
                    "criterion": "brain metastases",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "head CT with contrast"
                    ],
                    "criterion": "head CT with contrast",
                    "requirement_type": "requirement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "document either response or progression"
                    ],
                    "criterion": "brain metastases",
                    "requirement_type": "documentation of response or progression",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients with bone metastases as the only site(s) of measurable disease",
            "criterions": [
                {
                    "exact_snippets": [
                        "bone metastases"
                    ],
                    "criterion": "bone metastases",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "measurable disease"
                    ],
                    "criterion": "measurable disease",
                    "requirement_type": "site",
                    "expected_value": "bone"
                }
            ]
        },
        {
            "line": "* Patients with hepatic artery chemoembolization within the last 6 months (one month if there are other sites of measurable disease)",
            "criterions": [
                {
                    "exact_snippets": [
                        "hepatic artery chemoembolization within the last 6 months"
                    ],
                    "criterion": "hepatic artery chemoembolization",
                    "requirement_type": "recency",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 6
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "hepatic artery chemoembolization",
                        "one month if there are other sites of measurable disease"
                    ],
                    "criterion": "hepatic artery chemoembolization",
                    "requirement_type": "recency",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Patients who have been previously treated with radioactive directed therapies",
            "criterions": [
                {
                    "exact_snippets": [
                        "previously treated with radioactive directed therapies"
                    ],
                    "criterion": "radioactive directed therapies",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients who have been previously treated with epothilone",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients who have been previously treated with epothilone"
                    ],
                    "criterion": "epothilone treatment",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients with any peripheral neuropathy"
                    ],
                    "criterion": "peripheral neuropathy",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "unresolved diarrhea greater than Grade 1"
                    ],
                    "criterion": "diarrhea",
                    "requirement_type": "severity",
                    "expected_value": {
                        "operator": ">",
                        "value": 1
                    }
                }
            ]
        },
        {
            "line": "* Patients with severe cardiac insufficiency patients taking Coumadin or other warfarin-containing agents with the exception of low dose warfarin (1 mg or less) for the maintenance of in-dwelling lines or ports",
            "criterions": [
                {
                    "exact_snippets": [
                        "severe cardiac insufficiency"
                    ],
                    "criterion": "cardiac insufficiency",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                },
                {
                    "exact_snippets": [
                        "taking Coumadin or other warfarin-containing agents"
                    ],
                    "criterion": "warfarin-containing agents",
                    "requirement_type": "usage",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "low dose warfarin (1 mg or less)"
                    ],
                    "criterion": "warfarin dose",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Patients taking any experimental therapies history of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer, prostate cancer, or cervical cancer in situ",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients taking any experimental therapies"
                    ],
                    "criterion": "experimental therapies",
                    "requirement_type": "usage",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "history of another malignancy within 5 years prior to study entry"
                    ],
                    "criterion": "another malignancy",
                    "requirement_type": "history",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "except curatively treated non-melanoma skin cancer"
                    ],
                    "criterion": "non-melanoma skin cancer",
                    "requirement_type": "treatment status",
                    "expected_value": "curatively treated"
                },
                {
                    "exact_snippets": [
                        "except curatively treated",
                        "prostate cancer"
                    ],
                    "criterion": "prostate cancer",
                    "requirement_type": "treatment status",
                    "expected_value": "curatively treated"
                },
                {
                    "exact_snippets": [
                        "except curatively treated",
                        "cervical cancer in situ"
                    ],
                    "criterion": "cervical cancer in situ",
                    "requirement_type": "treatment status",
                    "expected_value": "curatively treated"
                }
            ]
        },
        {
            "line": "* Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae",
            "criterions": [
                {
                    "exact_snippets": [
                        "active or suspected acute or chronic uncontrolled infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "abcesses"
                    ],
                    "criterion": "abcesses",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "fistulae"
                    ],
                    "criterion": "fistulae",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Patients with a medical or psychiatric illness that would preclude study or informed consent and/or history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits",
            "criterions": [
                {
                    "exact_snippets": [
                        "medical or psychiatric illness"
                    ],
                    "criterion": "medical or psychiatric illness",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "history of noncompliance to medical regimens"
                    ],
                    "criterion": "noncompliance to medical regimens",
                    "requirement_type": "history",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "inability or unwillingness to return for all scheduled visits"
                    ],
                    "criterion": "ability to return for scheduled visits",
                    "requirement_type": "willingness",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* HIV+ patients",
            "criterions": [
                {
                    "exact_snippets": [
                        "HIV+ patients"
                    ],
                    "criterion": "HIV",
                    "requirement_type": "status",
                    "expected_value": "positive"
                }
            ]
        },
        {
            "line": "* Pregnant or lactating females.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "lactating"
                    ],
                    "criterion": "lactation",
                    "requirement_type": "status",
                    "expected_value": false
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal.)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Female patients"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specificity",
                    "expected_value": "female"
                },
                {
                    "exact_snippets": [
                        "negative serum pregnancy test"
                    ],
                    "criterion": "pregnancy test",
                    "requirement_type": "result",
                    "expected_value": "negative"
                },
                {
                    "exact_snippets": [
                        "at screening"
                    ],
                    "criterion": "pregnancy test",
                    "requirement_type": "timing",
                    "expected_value": "at screening"
                },
                {
                    "exact_snippets": [
                        "Not applicable to patients with bilateral oophorectomy"
                    ],
                    "criterion": "bilateral oophorectomy",
                    "requirement_type": "procedure history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Not applicable to patients with",
                        "hysterectomy"
                    ],
                    "criterion": "hysterectomy",
                    "requirement_type": "procedure history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Not applicable to patients who are postmenopausal"
                    ],
                    "criterion": "menopausal status",
                    "requirement_type": "status",
                    "expected_value": "postmenopausal"
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}