{
    "info": {
        "nct_id": "NCT00059982",
        "official_title": "Phase II Trial Of Perifosine In Locally Advanced, Unresectable Or Metastatic Pancreatic Adenocarcinoma",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the pancreas\n* Locally advanced, unresectable, or metastatic disease\n* Measurable disease\n* No known brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* WBC at least 3,500/mm^3\n* Platelet count at least 100,000/mm^3\n* Hemoglobin at least 10 g/dL\n\nHepatic\n\n* AST no greater than 2 times upper limit of normal (ULN)\n* Bilirubin no greater than 2 times ULN\n\nRenal\n\n* Creatinine no greater than 1.4 mg/dL\n\nCardiovascular\n\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No ongoing or active infection\n* No psychiatric illness or social situation that would preclude study compliance\n* No other concurrent illness that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior chemotherapy for pancreatic cancer\n* More than 6 months since prior chemotherapy for other diseases\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* At least 4 weeks since prior radiotherapy and recovered\n\nSurgery\n\n* At least 4 weeks since prior surgery and recovered\n\nOther\n\n* No other concurrent investigational agents for pancreatic cancer\n* No concurrent combination antiretroviral therapy for HIV-positive patients"
    },
    "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": "* Histologically confirmed adenocarcinoma of the pancreas",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed adenocarcinoma of the pancreas",
                    "criterion": "adenocarcinoma of the pancreas",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Locally advanced, unresectable, or metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Locally advanced",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable",
                    "criterion": "disease resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known brain metastases",
            "criterions": [
                {
                    "exact_snippets": "No known brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age",
            "criterions": [
                {
                    "exact_snippets": "Age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 and over",
            "criterions": [
                {
                    "exact_snippets": "18 and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Performance status",
            "criterions": [
                {
                    "exact_snippets": "Performance status",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG 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",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hematopoietic",
            "criterions": [
                {
                    "exact_snippets": "Hematopoietic",
                    "criterion": "hematopoietic",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WBC at least 3,500/mm^3",
            "criterions": [
                {
                    "exact_snippets": "WBC at least 3,500/mm^3",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3500,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count at least 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count at least 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin at least 10 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin at least 10 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic",
            "criterions": [
                {
                    "exact_snippets": "Hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST no greater than 2 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "AST no greater than 2 times upper limit of normal (ULN)",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin no greater than 2 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin no greater than 2 times ULN",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal",
            "criterions": [
                {
                    "exact_snippets": "Renal",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine no greater than 1.4 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Creatinine no greater than 1.4 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.4,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cardiovascular",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular",
                    "criterion": "cardiovascular condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No symptomatic congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "No symptomatic congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No unstable angina pectoris",
            "criterions": [
                {
                    "exact_snippets": "No unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No cardiac arrhythmia",
            "criterions": [
                {
                    "exact_snippets": "No cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No ongoing or active infection",
            "criterions": [
                {
                    "exact_snippets": "No ongoing or active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No psychiatric illness or social situation that would preclude study compliance",
            "criterions": [
                {
                    "exact_snippets": "No psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... social situation that would preclude study compliance",
                    "criterion": "social situation",
                    "requirements": [
                        {
                            "requirement_type": "impact on study compliance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent illness that would preclude study participation",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent illness",
                    "criterion": "concurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": "Biologic therapy",
            "criterions": [
                {
                    "exact_snippets": "Biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior chemotherapy for pancreatic cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy for pancreatic cancer",
                    "criterion": "prior chemotherapy for pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 6 months since prior chemotherapy for other diseases",
            "criterions": [
                {
                    "exact_snippets": "More than 6 months since prior chemotherapy for other diseases",
                    "criterion": "prior chemotherapy for other diseases",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Endocrine therapy",
            "criterions": [
                {
                    "exact_snippets": "Endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks since prior radiotherapy and recovered",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since prior radiotherapy",
                    "criterion": "time since prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery",
            "criterions": [
                {
                    "exact_snippets": "Surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks since prior surgery and recovered",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since prior surgery",
                    "criterion": "time since prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent investigational agents for pancreatic cancer",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent investigational agents for pancreatic cancer",
                    "criterion": "concurrent investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent combination antiretroviral therapy for HIV-positive patients",
            "criterions": [
                {
                    "exact_snippets": "No concurrent combination antiretroviral therapy for HIV-positive patients",
                    "criterion": "combination antiretroviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other",
            "criterions": []
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other",
            "criterions": []
        }
    ]
}