{
    "info": {
        "nct_id": "NCT00003882",
        "official_title": "Phase I Dose Finding Study of Anhydrovinblastine Administered as a 1-Hour Infusion Every 3 Weeks to Patients With Advanced Solid Tumors",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor unresponsive to existing therapy and for which no curative therapy exists No hematologic malignancies\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN (except with bone metastases) PT and PTT no greater than ULN Bilirubin no greater than ULN Renal: Creatinine no greater than ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No congestive heart failure, angina pectoris (even if medically controlled), uncontrolled hypertension, arrhythmias, elevated CPK or recent EKG changes At least one year since myocardial infarction Neurologic: No history of neurologic or psychiatric disorders (e.g., dementia, seizures) No concurrent peripheral neuropathy greater than grade 1 Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection No active pancreatitis Amylase no greater than the upper limit of normal No other serious systemic disease\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No concurrent immunotherapy No concurrent colony stimulating factors (unless evidence of neutropenic infection) Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) Prior taxanes and vinca alkaloids allowed with recovery (excluding alopecia any grade and peripheral neuropathy no greater than grade 1) No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered At least 6 weeks since prior extensive radiotherapy to greater than 20% of bone marrow No concurrent radiotherapy Surgery: Not specified Other: No other concurrent experimental drugs At least 30 days since other investigational drug"
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor unresponsive to existing therapy and for which no curative therapy exists No hematologic malignancies",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed advanced solid tumor",
                    "criterion": "advanced solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "unresponsive to existing therapy",
                    "criterion": "tumor response to existing therapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "unresponsive"
                        }
                    ]
                },
                {
                    "exact_snippets": "for which no curative therapy exists",
                    "criterion": "curative therapy availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No hematologic malignancies",
                    "criterion": "hematologic malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No concurrent immunotherapy No concurrent colony stimulating factors (unless evidence of neutropenic infection) Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) Prior taxanes and vinca alkaloids allowed with recovery (excluding alopecia any grade and peripheral neuropathy no greater than grade 1) No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered At least 6 weeks since prior extensive radiotherapy to greater than 20% of bone marrow No concurrent radiotherapy Surgery: Not specified Other: No other concurrent experimental drugs At least 30 days since other investigational drug",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since prior biologic therapy and recovered",
                    "criterion": "prior biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent immunotherapy",
                    "criterion": "concurrent immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent colony stimulating factors (unless evidence of neutropenic infection)",
                    "criterion": "concurrent colony stimulating factors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 4 weeks since prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "6 weeks for nitrosourea or mitomycin",
                    "criterion": "prior nitrosourea or mitomycin chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior taxanes and vinca alkaloids allowed with recovery (excluding alopecia any grade and peripheral neuropathy no greater than grade 1)",
                    "criterion": "prior taxanes and vinca alkaloids",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "alopecia",
                            "expected_value": "any grade"
                        },
                        {
                            "requirement_type": "peripheral neuropathy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No other concurrent chemotherapy",
                    "criterion": "concurrent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 4 weeks since prior radiotherapy and recovered",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 6 weeks since prior extensive radiotherapy to greater than 20% of bone marrow",
                    "criterion": "prior extensive radiotherapy to greater than 20% of bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent radiotherapy",
                    "criterion": "concurrent radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other concurrent experimental drugs",
                    "criterion": "concurrent experimental drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 30 days since other investigational drug",
                    "criterion": "other investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN (except with bone metastases) PT and PTT no greater than ULN Bilirubin no greater than ULN Renal: Creatinine no greater than ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No congestive heart failure, angina pectoris (even if medically controlled), uncontrolled hypertension, arrhythmias, elevated CPK or recent EKG changes At least one year since myocardial infarction Neurologic: No history of neurologic or psychiatric disorders (e.g., dementia, seizures) No concurrent peripheral neuropathy greater than grade 1 Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection No active pancreatitis Amylase no greater than the upper limit of normal No other serious systemic disease",
            "criterions": [
                {
                    "exact_snippets": "Age: 18 and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "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 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Absolute neutrophil count at least 1500/mm3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count at least 100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin at least 10 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)",
                    "criterion": "SGOT and SGPT",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": "2.5 times ULN"
                        }
                    ]
                },
                {
                    "exact_snippets": "Alkaline phosphatase no greater than 2.5 times ULN (except with bone metastases)",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": "2.5 times ULN"
                        }
                    ]
                },
                {
                    "exact_snippets": "PT and PTT no greater than ULN",
                    "criterion": "PT and PTT",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": "ULN"
                        }
                    ]
                },
                {
                    "exact_snippets": "Bilirubin no greater than ULN",
                    "criterion": "bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": "ULN"
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine no greater than ULN",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": "ULN"
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine clearance at least 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No angina pectoris (even if medically controlled)",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No uncontrolled hypertension",
                    "criterion": "uncontrolled hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No arrhythmias",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No elevated CPK",
                    "criterion": "elevated CPK",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No recent EKG changes",
                    "criterion": "recent EKG changes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "At least one year since myocardial infarction",
                    "criterion": "time since myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of neurologic or psychiatric disorders (e.g., dementia, seizures)",
                    "criterion": "history of neurologic or psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent peripheral neuropathy greater than grade 1",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Not pregnant or nursing",
                    "criterion": "pregnancy or nursing",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Fertile patients must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No active pancreatitis",
                    "criterion": "active pancreatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Amylase no greater than the upper limit of normal",
                    "criterion": "amylase",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": "ULN"
                        }
                    ]
                },
                {
                    "exact_snippets": "No other serious systemic disease",
                    "criterion": "serious systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ]
}