{
    "info": {
        "nct_id": "NCT00376948",
        "official_title": "Phase II Trial of Novasoy®, Gemcitabine, and Erlotinib in Locally Advanced or Metastatic Pancreatic Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 21 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed pancreatic adenocarcinoma\n\n  * Locally advanced or metastatic disease by radiological evidence\n* Must have biopsy material consisting of 10 unstained slides or paraffin-embedded tissue blocks available for correlative studies\n* No endocrine tumor or lymphoma of the pancreas\n* No history of CNS (central nervous system) metastases\n\nPATIENT CHARACTERISTICS:\n\n* SWOG (Southwest Oncology Group) performance status 0-1\n* Life expectancy ≥ 12 weeks\n* Platelet count ≥ 100,000/mm^3\n* Absolute neutrophil count ≥ 1,500/mm^3\n* Bilirubin < 2.0 mg/dL\n* AST (aspartate aminotransferase) and ALT (alanine aminotransferase) < 1.5 times upper limit of normal\n* Creatinine < 1.5 mg/dL\n* Albumin > 2.5 g/dL\n* INR (international normalized ratio) < 1.3 (in the absence of ongoing treatment with warfarin)\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No active infection\n* No condition that would limit the ability to receive oral medications\n* No requirement for a gastrostomy tube for the administration of drugs\n* No serious concurrent systemic disorder, that, in the opinion of the investigator, is incompatible with the study\n* No active second primary malignancy within the past year except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin\n* No allergy to any study drug\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy or radiotherapy for metastatic disease\n\n  * Prior adjuvant chemotherapy allowed provided it was completed at least 6 months ago\n* No prior gemcitabine hydrochloride or epidermal growth factor receptor-inhibiting agents\n* No other concurrent chemotherapy, immunotherapy, tumor-directed hormonal therapy, or radiotherapy\n* No other concurrent investigational agents\n* No other concurrent antitumor therapy"
    },
    "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 21 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 21 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "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": "DISEASE CHARACTERISTICS:",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed pancreatic adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed pancreatic adenocarcinoma",
                    "criterion": "pancreatic adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Locally advanced or metastatic disease by radiological evidence",
            "criterions": [
                {
                    "exact_snippets": "Locally advanced or metastatic disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "radiological evidence",
                    "criterion": "evidence type",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "radiological"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have biopsy material consisting of 10 unstained slides or paraffin-embedded tissue blocks available for correlative studies",
            "criterions": [
                {
                    "exact_snippets": "biopsy material consisting of 10 unstained slides or paraffin-embedded tissue blocks available",
                    "criterion": "biopsy material",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "unstained slides"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No endocrine tumor or lymphoma of the pancreas",
            "criterions": [
                {
                    "exact_snippets": "No endocrine tumor",
                    "criterion": "endocrine tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... lymphoma of the pancreas",
                    "criterion": "lymphoma of the pancreas",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of CNS (central nervous system) metastases",
            "criterions": [
                {
                    "exact_snippets": "No history of CNS (central nervous system) metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* SWOG (Southwest Oncology Group) performance status 0-1",
            "criterions": [
                {
                    "exact_snippets": "SWOG (Southwest Oncology Group) performance status 0-1",
                    "criterion": "SWOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy ≥ 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* 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": "* Bilirubin < 2.0 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin < 2.0 mg/dL",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST (aspartate aminotransferase) and ALT (alanine aminotransferase) < 1.5 times upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "AST (aspartate aminotransferase) ... < 1.5 times upper limit of normal",
                    "criterion": "AST (aspartate aminotransferase)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT (alanine aminotransferase) < 1.5 times upper limit of normal",
                    "criterion": "ALT (alanine aminotransferase)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine < 1.5 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Creatinine < 1.5 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Albumin > 2.5 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Albumin > 2.5 g/dL",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* INR (international normalized ratio) < 1.3 (in the absence of ongoing treatment with warfarin)",
            "criterions": [
                {
                    "exact_snippets": "INR (international normalized ratio) < 1.3",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of ongoing treatment with warfarin",
                    "criterion": "ongoing treatment with warfarin",
                    "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 active infection",
            "criterions": [
                {
                    "exact_snippets": "No active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No condition that would limit the ability to receive oral medications",
            "criterions": [
                {
                    "exact_snippets": "No condition that would limit the ability to receive oral medications",
                    "criterion": "condition limiting ability to receive oral medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No requirement for a gastrostomy tube for the administration of drugs",
            "criterions": [
                {
                    "exact_snippets": "No requirement for a gastrostomy tube for the administration of drugs",
                    "criterion": "gastrostomy tube",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No serious concurrent systemic disorder, that, in the opinion of the investigator, is incompatible with the study",
            "criterions": [
                {
                    "exact_snippets": "No serious concurrent systemic disorder",
                    "criterion": "serious concurrent systemic disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active second primary malignancy within the past year except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin",
            "criterions": [
                {
                    "exact_snippets": "No active second primary malignancy within the past year",
                    "criterion": "active second primary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past year"
                        }
                    ]
                },
                {
                    "exact_snippets": "except in situ carcinoma of the cervix",
                    "criterion": "in situ carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... adequately treated basal cell carcinoma of the skin",
                    "criterion": "adequately treated basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No allergy to any study drug",
            "criterions": [
                {
                    "exact_snippets": "No allergy to any study drug",
                    "criterion": "allergy to study drug",
                    "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": "* No prior chemotherapy or radiotherapy for metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy ... for metastatic disease",
                    "criterion": "prior chemotherapy for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... radiotherapy for metastatic disease",
                    "criterion": "prior radiotherapy for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior adjuvant chemotherapy allowed provided it was completed at least 6 months ago",
            "criterions": [
                {
                    "exact_snippets": "Prior adjuvant chemotherapy allowed",
                    "criterion": "prior adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "provided it was completed at least 6 months ago",
                    "criterion": "completion of prior adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior gemcitabine hydrochloride or epidermal growth factor receptor-inhibiting agents",
            "criterions": [
                {
                    "exact_snippets": "No prior gemcitabine hydrochloride",
                    "criterion": "prior gemcitabine hydrochloride",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... epidermal growth factor receptor-inhibiting agents",
                    "criterion": "prior epidermal growth factor receptor-inhibiting agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent chemotherapy, immunotherapy, tumor-directed hormonal therapy, or radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent chemotherapy",
                    "criterion": "concurrent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other concurrent ... immunotherapy",
                    "criterion": "concurrent immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other concurrent ... tumor-directed hormonal therapy",
                    "criterion": "concurrent tumor-directed hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other concurrent ... radiotherapy",
                    "criterion": "concurrent radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent investigational agents",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent investigational agents",
                    "criterion": "concurrent investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent antitumor therapy",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent antitumor therapy",
                    "criterion": "concurrent antitumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ]
}