{
    "info": {
        "nct_id": "NCT00003294",
        "official_title": "Initial Clinical Evaluation of the Combination of Paclitaxel and Carboplatin With Modulation of Toxicity With GCSF and Amifostine",
        "inclusion_criteria": "Healthy volunteers allowed",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically proven recurrent or metastatic malignant disease not amenable to curative surgery, radiotherapy, conventional chemotherapy, or investigational therapy of higher priority Priority given to patients with lung cancer or cancers with tumors easily available for biopsy No CNS disease unless stable post radiation\n\nPATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 50 mL/min Cardiovascular: Systolic blood pressure at least 90 mm Hg No severe heart decompensation No clinically significant cardiac arrhythmia on EKG No inability to tolerate bradycardia Other: No active, uncontrolled infection No nonmalignant systemic disease Not pregnant or nursing Effective contraception required of fertile patients\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immune stimulating agents Chemotherapy: At least 3 weeks since chemotherapy (6 weeks since nitrosourea or mitomycin) and recovered No prior paclitaxel or carboplatin No concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy Radiotherapy: At least 3 weeks since radiotherapy to major bone marrow bearing areas and recovered Concurrent radiotherapy allowed for vital indications or pain relief Surgery: At least 3 weeks since surgery"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS: Histologically proven recurrent or metastatic malignant disease not amenable to curative surgery, radiotherapy, conventional chemotherapy, or investigational therapy of higher priority Priority given to patients with lung cancer or cancers with tumors easily available for biopsy No CNS disease unless stable post radiation",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven recurrent or metastatic malignant disease",
                    "criterion": "malignant disease",
                    "requirements": [
                        {
                            "requirement_type": "histological proof",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "recurrence or metastasis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not amenable to curative surgery, radiotherapy, conventional chemotherapy, or investigational therapy of higher priority",
                    "criterion": "treatment amenability",
                    "requirements": [
                        {
                            "requirement_type": "amenability to curative surgery",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "amenability to radiotherapy",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "amenability to conventional chemotherapy",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "amenability to investigational therapy of higher priority",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Priority given to patients with lung cancer",
                    "criterion": "lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "priority",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cancers with tumors easily available for biopsy",
                    "criterion": "tumor biopsy availability",
                    "requirements": [
                        {
                            "requirement_type": "ease of availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No CNS disease unless stable post radiation",
                    "criterion": "CNS disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "stability post radiation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 50 mL/min Cardiovascular: Systolic blood pressure at least 90 mm Hg No severe heart decompensation No clinically significant cardiac arrhythmia on EKG No inability to tolerate bradycardia Other: No active, uncontrolled infection No nonmalignant systemic disease Not pregnant or nursing Effective contraception required of fertile patients",
            "criterions": [
                {
                    "exact_snippets": "Age: Not specified",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: ECOG 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "ECOG"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Life expectancy: At least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: WBC at least 4,000/mm3",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count at least 100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic: Bilirubin no greater than 1.5 mg/dL",
                    "criterion": "bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal: Creatinine no greater than 1.5 mg/dL",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine clearance at least 50 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiovascular: Systolic blood pressure at least 90 mm Hg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "pressure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No severe heart decompensation",
                    "criterion": "severe heart decompensation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No clinically significant cardiac arrhythmia on EKG",
                    "criterion": "clinically significant cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No inability to tolerate bradycardia",
                    "criterion": "inability to tolerate bradycardia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No active, uncontrolled infection",
                    "criterion": "active, uncontrolled infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No nonmalignant systemic disease",
                    "criterion": "nonmalignant systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Not pregnant or nursing",
                    "criterion": "pregnancy or nursing",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Effective contraception required of fertile patients",
                    "criterion": "effective contraception",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immune stimulating agents Chemotherapy: At least 3 weeks since chemotherapy (6 weeks since nitrosourea or mitomycin) and recovered No prior paclitaxel or carboplatin No concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy Radiotherapy: At least 3 weeks since radiotherapy to major bone marrow bearing areas and recovered Concurrent radiotherapy allowed for vital indications or pain relief Surgery: At least 3 weeks since surgery",
            "criterions": [
                {
                    "exact_snippets": "No concurrent immune stimulating agents",
                    "criterion": "concurrent immune stimulating agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 3 weeks since chemotherapy",
                    "criterion": "time since chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "6 weeks since nitrosourea or mitomycin",
                    "criterion": "time since nitrosourea or mitomycin",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior paclitaxel or carboplatin",
                    "criterion": "prior paclitaxel or carboplatin",
                    "requirements": [
                        {
                            "requirement_type": "prior use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent chemotherapy",
                    "criterion": "concurrent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent hormone therapy",
                    "criterion": "concurrent hormone therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 3 weeks since radiotherapy to major bone marrow bearing areas",
                    "criterion": "time since radiotherapy to major bone marrow bearing areas",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent radiotherapy allowed for vital indications or pain relief",
                    "criterion": "concurrent radiotherapy for vital indications or pain relief",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 3 weeks since surgery",
                    "criterion": "time since surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}