{
    "info": {
        "nct_id": "NCT00006376",
        "official_title": "A Phase II Trial of R115777, an Oral Farnesyltransferase Inhibitor (FTI) in Previously Untreated Patients With Advanced Urothelial Tract Transitional Cell Carcinoma",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the urothelial tract not curable by surgery or radiotherapy Bladder, renal pelvis, or ureter Stage II, III, or IV (T2-4, N0-3, M0-1) with unresectable disease Poorly differentiated transitional cell carcinoma or predominant transitional cell carcinoma with foci of squamous differentiation or rare foci of adenocarcinoma allowed No adenocarcinoma, small cell carcinoma, sarcoma, or squamous cell carcinoma Bidimensionally measurable disease No disease confined to the bladder only No soft tissue disease irradiated within the past 2 months No known active CNS disease\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: SGOT no greater than 2 times upper limit of normal (ULN) Bilirubin normal Renal: Creatinine no greater than 2 times ULN Other: No unresolved, active bacterial infection requiring antibiotics No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent myeloid colony stimulating factors Chemotherapy: At least 12 months since prior adjuvant or neoadjuvant chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered Surgery: At least 4 weeks since prior surgery and recovered Other: No prior systemic therapy (including investigational agents) for metastatic bladder cancer At least 4 weeks since prior intravesical therapy and recovered At least 30 days since prior participation in other investigational drug trial No concurrent intravesical therapy No other concurrent therapy for cancer"
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the urothelial tract not curable by surgery or radiotherapy Bladder, renal pelvis, or ureter Stage II, III, or IV (T2-4, N0-3, M0-1) with unresectable disease Poorly differentiated transitional cell carcinoma or predominant transitional cell carcinoma with foci of squamous differentiation or rare foci of adenocarcinoma allowed No adenocarcinoma, small cell carcinoma, sarcoma, or squamous cell carcinoma Bidimensionally measurable disease No disease confined to the bladder only No soft tissue disease irradiated within the past 2 months No known active CNS disease",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed transitional cell carcinoma of the urothelial tract",
                        "criterion": "transitional cell carcinoma",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "not curable by surgery or radiotherapy",
                        "criterion": "curability by surgery or radiotherapy",
                        "requirement": {
                            "requirement_type": "curability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Bladder, renal pelvis, or ureter",
                        "criterion": "location of carcinoma",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "bladder",
                                "renal pelvis",
                                "ureter"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Stage II, III, or IV (T2-4, N0-3, M0-1) with unresectable disease",
                        "criterion": "stage of disease",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "II",
                                "III",
                                "IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Stage II, III, or IV (T2-4, N0-3, M0-1) with unresectable disease",
                        "criterion": "stage of disease",
                        "requirement": {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Poorly differentiated transitional cell carcinoma or predominant transitional cell carcinoma with foci of squamous differentiation or rare foci of adenocarcinoma allowed",
                        "criterion": "differentiation and cell type",
                        "requirement": {
                            "requirement_type": "differentiation",
                            "expected_value": "poorly differentiated"
                        }
                    },
                    {
                        "exact_snippets": "Poorly differentiated transitional cell carcinoma or predominant transitional cell carcinoma with foci of squamous differentiation or rare foci of adenocarcinoma allowed",
                        "criterion": "differentiation and cell type",
                        "requirement": {
                            "requirement_type": "cell type",
                            "expected_value": [
                                "predominant transitional cell carcinoma with foci of squamous differentiation",
                                "rare foci of adenocarcinoma"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "No adenocarcinoma, small cell carcinoma, sarcoma, or squamous cell carcinoma",
                        "criterion": "exclusion of certain carcinomas",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "adenocarcinoma",
                                "small cell carcinoma",
                                "sarcoma",
                                "squamous cell carcinoma"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Bidimensionally measurable disease",
                        "criterion": "measurability of disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": "bidimensionally measurable"
                        }
                    },
                    {
                        "exact_snippets": "No disease confined to the bladder only",
                        "criterion": "disease confinement",
                        "requirement": {
                            "requirement_type": "confinement",
                            "expected_value": "not confined to bladder only"
                        }
                    },
                    {
                        "exact_snippets": "No soft tissue disease irradiated within the past 2 months",
                        "criterion": "recent irradiation of soft tissue disease",
                        "requirement": {
                            "requirement_type": "irradiation",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No known active CNS disease",
                        "criterion": "active CNS disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: SGOT no greater than 2 times upper limit of normal (ULN) Bilirubin normal Renal: Creatinine no greater than 2 times ULN Other: No unresolved, active bacterial infection requiring antibiotics No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception",
                "criterions": [
                    {
                        "exact_snippets": "Age: 18 and over",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Performance status: ECOG 0-2",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "scale",
                            "expected_value": "ECOG 0-2"
                        }
                    },
                    {
                        "exact_snippets": "Life expectancy: Not specified",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "specification",
                            "expected_value": "Not specified"
                        }
                    },
                    {
                        "exact_snippets": "Hematopoietic: Absolute neutrophil count greater than 1,500/mm3",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelet count greater than 100,000/mm3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hepatic: SGOT no greater than 2 times upper limit of normal (ULN)",
                        "criterion": "SGOT",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Bilirubin normal",
                        "criterion": "bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "Renal: Creatinine no greater than 2 times ULN",
                        "criterion": "creatinine",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No unresolved, active bacterial infection requiring antibiotics",
                        "criterion": "active bacterial infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission",
                        "criterion": "prior malignancy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 5 years"
                        }
                    },
                    {
                        "exact_snippets": "No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission",
                        "criterion": "prior malignancy",
                        "requirement": {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "adequately treated basal cell or squamous cell skin cancer",
                                "carcinoma in situ of the cervix",
                                "adequately treated stage I or II cancer in complete remission"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Not pregnant or nursing",
                        "criterion": "pregnancy or nursing status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Negative pregnancy test",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "Fertile patients must use effective contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent myeloid colony stimulating factors Chemotherapy: At least 12 months since prior adjuvant or neoadjuvant chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered Surgery: At least 4 weeks since prior surgery and recovered Other: No prior systemic therapy (including investigational agents) for metastatic bladder cancer At least 4 weeks since prior intravesical therapy and recovered At least 30 days since prior participation in other investigational drug trial No concurrent intravesical therapy No other concurrent therapy for cancer",
                "criterions": [
                    {
                        "exact_snippets": "No concurrent myeloid colony stimulating factors",
                        "criterion": "concurrent myeloid colony stimulating factors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "At least 12 months since prior adjuvant or neoadjuvant chemotherapy",
                        "criterion": "time since prior adjuvant or neoadjuvant chemotherapy",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "recovered",
                        "criterion": "recovery from prior adjuvant or neoadjuvant chemotherapy",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Endocrine therapy: Not specified",
                        "criterion": "endocrine therapy",
                        "requirement": {
                            "requirement_type": "specification",
                            "expected_value": "Not specified"
                        }
                    },
                    {
                        "exact_snippets": "At least 4 weeks since prior radiotherapy",
                        "criterion": "time since prior radiotherapy",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "recovered",
                        "criterion": "recovery from prior radiotherapy",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "At least 4 weeks since prior surgery",
                        "criterion": "time since prior surgery",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "recovered",
                        "criterion": "recovery from prior surgery",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "No prior systemic therapy (including investigational agents) for metastatic bladder cancer",
                        "criterion": "prior systemic therapy for metastatic bladder cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "At least 4 weeks since prior intravesical therapy",
                        "criterion": "time since prior intravesical therapy",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "recovered",
                        "criterion": "recovery from prior intravesical therapy",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "At least 30 days since prior participation in other investigational drug trial",
                        "criterion": "time since prior participation in other investigational drug trial",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No concurrent intravesical therapy",
                        "criterion": "concurrent intravesical therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No other concurrent therapy for cancer",
                        "criterion": "other concurrent therapy for cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ]
}