{
    "info": {
        "nct_id": "NCT00755157",
        "official_title": "A Phase II Study of the Combination of Metronomic Docetaxel and Bevacizumab as 2nd Line Treatment in Patients With Small Cell Lung Cancer (SCLC)",
        "inclusion_criteria": "* Histologically or cytologically confirmed, metastatic (stage IV) small cell lung cancer\n* One previous chemotherapy regimen metastatic SCLC\n* Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm\n* Age ≥ 18 years\n* Performance status (WHO) 0-2\n* Life expectancy of at least 12 weeks\n* Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 2.5 upper normal limit in the absence of liver metastases or ≤ 5 upper normal limit in the presence of liver metastases), and renal function (Creatinine ≤ 1,5 upper normal limit)\n* Patients must be able to understand the nature of this study and give written informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Second primary malignancy, except for non-melanoma skin cancer\n* Pregnant or lactating women\n* Any serious, uncontrolled comorbidity on the investigator's judgment\n* Uncontrolled infection\n* Any sustained chronic toxicity > grade 2 according to the NCI CTCAE (version 3.0)\n* Brain metastases, except if radiated and asymptomatic\n* Radiotherapy within the previous 4 weeks\n* Previous radiotherapy to the only measurable lesion\n* Proteinuria ≥ 500 mgr of protein daily\n* Hemoptysis > 10 cc per event\n* Clinically significant hematemesis\n* Centrally located lesion or in contact with major vessels\n* Pulmonary lesion with cavitation\n* Documented hemorrhagic diathesis or coagulation disorder\n* Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF < normal, ventricular arrhythmia, uncontrolled hypertension)\n* Thrombotic event within the previous 6 months\n* Concurrent use of aspirin > 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents\n* Concurrent treatment with other anti-cancer drug\n* Major surgical procedure within the previous 4 weeks\n* Serum Να+ < 120 mg/dL",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed, metastatic (stage IV) small cell lung cancer",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic (stage IV) small cell lung cancer",
                    "criterion": "cancer type and stage",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "small cell lung cancer"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic (stage IV)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* One previous chemotherapy regimen metastatic SCLC",
            "criterions": [
                {
                    "exact_snippets": "One previous chemotherapy regimen",
                    "criterion": "previous chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic SCLC",
                    "criterion": "metastatic SCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status (WHO) 0-2",
            "criterions": [
                {
                    "exact_snippets": "Performance status (WHO) 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "WHO"
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be able to understand the nature of this study and give written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patients must be able to understand the nature of this study",
                    "criterion": "understanding of study",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "give written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Second primary malignancy, except for non-melanoma skin cancer",
            "criterions": [
                {
                    "exact_snippets": "Second primary malignancy, except for non-melanoma skin cancer",
                    "criterion": "second primary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any serious, uncontrolled comorbidity on the investigator's judgment",
            "criterions": [
                {
                    "exact_snippets": "serious, uncontrolled comorbidity",
                    "criterion": "comorbidity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled infection",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any sustained chronic toxicity > grade 2 according to the NCI CTCAE (version 3.0)",
            "criterions": [
                {
                    "exact_snippets": "sustained chronic toxicity > grade 2 according to the NCI CTCAE (version 3.0)",
                    "criterion": "chronic toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Brain metastases, except if radiated and asymptomatic",
            "criterions": [
                {
                    "exact_snippets": "Brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except if radiated",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "radiated"
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiotherapy within the previous 4 weeks",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy within the previous 4 weeks",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous radiotherapy to the only measurable lesion",
            "criterions": [
                {
                    "exact_snippets": "Previous radiotherapy to the only measurable lesion",
                    "criterion": "previous radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "target",
                            "expected_value": "only measurable lesion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Proteinuria ≥ 500 mgr of protein daily",
            "criterions": [
                {
                    "exact_snippets": "Proteinuria ≥ 500 mgr of protein daily",
                    "criterion": "proteinuria",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 500,
                                "unit": "mgr of protein daily"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoptysis > 10 cc per event",
            "criterions": [
                {
                    "exact_snippets": "Hemoptysis > 10 cc per event",
                    "criterion": "hemoptysis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "cc per event"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant hematemesis",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant hematemesis",
                    "criterion": "hematemesis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Centrally located lesion or in contact with major vessels",
            "criterions": [
                {
                    "exact_snippets": "Centrally located lesion",
                    "criterion": "lesion location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "central"
                        }
                    ]
                },
                {
                    "exact_snippets": "in contact with major vessels",
                    "criterion": "lesion contact",
                    "requirements": [
                        {
                            "requirement_type": "contact",
                            "expected_value": "major vessels"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pulmonary lesion with cavitation",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary lesion",
                    "criterion": "pulmonary lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cavitation",
                    "criterion": "cavitation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documented hemorrhagic diathesis or coagulation disorder",
            "criterions": [
                {
                    "exact_snippets": "Documented hemorrhagic diathesis",
                    "criterion": "hemorrhagic diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "coagulation disorder",
                    "criterion": "coagulation disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF < normal, ventricular arrhythmia, uncontrolled hypertension)",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "class II-IV NYHA congestive heart failure",
                    "criterion": "NYHA congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "class",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "class"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "class"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within the previous 4 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "LVEF < normal",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "comparison to normal",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular arrhythmia",
                    "criterion": "ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "uncontrolled hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Thrombotic event within the previous 6 months",
            "criterions": [
                {
                    "exact_snippets": "Thrombotic event within the previous 6 months",
                    "criterion": "thrombotic event",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent use of aspirin > 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents",
            "criterions": [
                {
                    "exact_snippets": "Concurrent use of aspirin > 325 mgr daily",
                    "criterion": "aspirin use",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 325,
                                "unit": "mgr"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent use of ... low molecular weight heparin in therapeutic dose",
                    "criterion": "low molecular weight heparin use",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": "therapeutic dose"
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent use of ... warfarin",
                    "criterion": "warfarin use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent use of ... acenocoumarol",
                    "criterion": "acenocoumarol use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent use of ... non-steroid anti-inflammatory agents",
                    "criterion": "non-steroid anti-inflammatory agents use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent treatment with other anti-cancer drug",
            "criterions": [
                {
                    "exact_snippets": "Concurrent treatment with other anti-cancer drug",
                    "criterion": "concurrent treatment with other anti-cancer drug",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgical procedure within the previous 4 weeks",
            "criterions": [
                {
                    "exact_snippets": "Major surgical procedure within the previous 4 weeks",
                    "criterion": "major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum Να+ < 120 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Serum Να+ < 120 mg/dL",
                    "criterion": "serum sodium (Na+) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 120,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 2.5 upper normal limit in the absence of liver metastases or ≤ 5 upper normal limit in the presence of liver metastases), and renal function (Creatinine ≤ 1,5 upper normal limit)",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow (ANC ≥ 1,500/mm3",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate bone marrow ... PLT ≥ 100,000/mm3",
                    "criterion": "PLT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate bone marrow ... Hgb ≥ 11 g/dL",
                    "criterion": "Hgb",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 11,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "liver (Bilirubin ≤ 1.5 upper normal limit",
                    "criterion": "Bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "upper normal limit"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "liver ... SGOT/SGPT ≤ 2.5 upper normal limit in the absence of liver metastases",
                    "criterion": "SGOT/SGPT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "upper normal limit"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "liver ... SGOT/SGPT ≤ 5 upper normal limit in the presence of liver metastases",
                    "criterion": "SGOT/SGPT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "upper normal limit"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "renal function (Creatinine ≤ 1,5 upper normal limit",
                    "criterion": "Creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "upper normal limit"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}