{
    "info": {
        "nct_id": "NCT00176631",
        "official_title": "A Phase II Trial of Licorice Root and Docetaxel in Patients With Hormone Refractory Prostate Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Diagnosis of prostate adenocarcinoma\n\n  * Metastatic disease\n* Must have failed initial hormonal therapy and have disease progression after at least one chemotherapy regimen*, meeting any of the following criteria:\n\n  * Progressive PSA ≥ 5 ng/mL, as evidenced by 2 separate measurements taken ≥ 2 weeks apart with the second PSA measurement greater than the first one and PSA measurement at screening greater than the first one\n  * Progressive measurable disease (e.g., changes in the size of lymph nodes or parenchymal masses or appearance of new lesions on physical examination or x-ray/CT scan) with a PSA level at screening ≥ 5 ng/mL\n  * Progressive bone metastasis (e.g., presence of new lesions on a bone scan) with a PSA level at screening ≥ 5 ng/mL NOTE: *Prior chemotherapy must include a taxane therapy, but disease progression does not have to follow taxane therapy\n* Patients must maintain primary androgen ablation (hormonal) therapy AND experience disease progression while not receiving antiandrogen therapy\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-1\n* Life expectancy ≥ 6 months\n* Absolute neutrophil count ≥ 1,500/mm^3\n* Platelet count ≥ 100,000/mm^3\n* WBC ≥ 3,500/mm^3\n* Bilirubin ≤ 1.2 mg/dL\n* Creatinine ≤ 1.5 mg/dL\n* SGOT or SGPT ≤ 1.5 times upper limit of normal\n* No other prior malignancy unless treated with curative intent and free of disease for the time period considered appropriate for the specific cancer\n* No uncontrolled hypertension\n* No active infections\n* No known HIV positivity\n* No uncontrolled medical condition that would preclude study therapy\n* No diagnosis of major depression or suicidal ideation\n* No problems with oral absorption\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* More than 4 weeks since prior surgery or radiotherapy and recovered\n* At least 4 weeks since prior flutamide\n* At least 6 weeks since prior bicalutamide\n* No prior or concurrent herbal supplements or thiazide diuretics\n* No other concurrent investigational or commercial agents or therapies"
    },
    "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 be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 120 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 120 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Diagnosis of prostate adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of prostate adenocarcinoma",
                    "criterion": "prostate adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have failed initial hormonal therapy and have disease progression after at least one chemotherapy regimen*, meeting any of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Must have failed initial hormonal therapy",
                    "criterion": "initial hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "failure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "disease progression after at least one chemotherapy regimen",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "after chemotherapy regimens",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressive PSA ≥ 5 ng/mL, as evidenced by 2 separate measurements taken ≥ 2 weeks apart with the second PSA measurement greater than the first one and PSA measurement at screening greater than the first one",
            "criterions": [
                {
                    "exact_snippets": "Progressive PSA ≥ 5 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "2 separate measurements taken ≥ 2 weeks apart",
                    "criterion": "PSA measurement interval",
                    "requirements": [
                        {
                            "requirement_type": "interval",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "second PSA measurement greater than the first one",
                    "criterion": "PSA measurement comparison",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": "second > first"
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA measurement at screening greater than the first one",
                    "criterion": "PSA screening comparison",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": "screening > first"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressive measurable disease (e.g., changes in the size of lymph nodes or parenchymal masses or appearance of new lesions on physical examination or x-ray/CT scan) with a PSA level at screening ≥ 5 ng/mL",
            "criterions": [
                {
                    "exact_snippets": "Progressive measurable disease (e.g., changes in the size of lymph nodes or parenchymal masses or appearance of new lesions on physical examination or x-ray/CT scan)",
                    "criterion": "progressive measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA level at screening ≥ 5 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressive bone metastasis (e.g., presence of new lesions on a bone scan) with a PSA level at screening ≥ 5 ng/mL NOTE: *Prior chemotherapy must include a taxane therapy, but disease progression does not have to follow taxane therapy",
            "criterions": [
                {
                    "exact_snippets": "Progressive bone metastasis (e.g., presence of new lesions on a bone scan)",
                    "criterion": "progressive bone metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA level at screening ≥ 5 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior chemotherapy must include a taxane therapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "taxane therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must maintain primary androgen ablation (hormonal) therapy AND experience disease progression while not receiving antiandrogen therapy",
            "criterions": [
                {
                    "exact_snippets": "Patients must maintain primary androgen ablation (hormonal) therapy",
                    "criterion": "primary androgen ablation therapy",
                    "requirements": [
                        {
                            "requirement_type": "maintenance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "experience disease progression while not receiving antiandrogen therapy",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "while not receiving antiandrogen therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy ≥ 6 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1,500/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1,500/mm^3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥ 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WBC ≥ 3,500/mm^3",
            "criterions": [
                {
                    "exact_snippets": "WBC ≥ 3,500/mm^3",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3500,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin ≤ 1.2 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin ≤ 1.2 mg/dL",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.2,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine ≤ 1.5 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Creatinine ≤ 1.5 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* SGOT or SGPT ≤ 1.5 times upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "SGOT or SGPT ≤ 1.5 times upper limit of normal",
                    "criterion": "SGOT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "SGOT or SGPT ≤ 1.5 times upper limit of normal",
                    "criterion": "SGPT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other prior malignancy unless treated with curative intent and free of disease for the time period considered appropriate for the specific cancer",
            "criterions": [
                {
                    "exact_snippets": "No other prior malignancy",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unless treated with curative intent",
                    "criterion": "treatment intent",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                },
                {
                    "exact_snippets": "free of disease for the time period considered appropriate for the specific cancer",
                    "criterion": "disease-free period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "appropriate for the specific cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncontrolled hypertension",
            "criterions": [
                {
                    "exact_snippets": "No uncontrolled hypertension",
                    "criterion": "uncontrolled hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active infections",
            "criterions": [
                {
                    "exact_snippets": "No active infections",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known HIV positivity",
            "criterions": [
                {
                    "exact_snippets": "No known HIV positivity",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "positivity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncontrolled medical condition that would preclude study therapy",
            "criterions": [
                {
                    "exact_snippets": "No uncontrolled medical condition",
                    "criterion": "uncontrolled medical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "would preclude study therapy",
                    "criterion": "ability to undergo study therapy",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No diagnosis of major depression or suicidal ideation",
            "criterions": [
                {
                    "exact_snippets": "No diagnosis of major depression",
                    "criterion": "major depression",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... suicidal ideation",
                    "criterion": "suicidal ideation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No problems with oral absorption",
            "criterions": [
                {
                    "exact_snippets": "No problems with oral absorption",
                    "criterion": "oral absorption",
                    "requirements": [
                        {
                            "requirement_type": "problems",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "See Disease Characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since prior surgery or radiotherapy and recovered",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since prior surgery",
                    "criterion": "time since prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "More than 4 weeks since prior ... radiotherapy",
                    "criterion": "time since prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from prior surgery or radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks since prior flutamide",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since prior flutamide",
                    "criterion": "time since prior flutamide",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 6 weeks since prior bicalutamide",
            "criterions": [
                {
                    "exact_snippets": "At least 6 weeks since prior bicalutamide",
                    "criterion": "time since prior bicalutamide",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior or concurrent herbal supplements or thiazide diuretics",
            "criterions": [
                {
                    "exact_snippets": "No prior or concurrent herbal supplements",
                    "criterion": "herbal supplements",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior or concurrent ... thiazide diuretics",
                    "criterion": "thiazide diuretics",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent investigational or commercial agents or therapies",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent investigational or commercial agents or therapies",
                    "criterion": "concurrent investigational or commercial agents or therapies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        }
    ]
}