{
    "info": {
        "nct_id": "NCT00004182",
        "official_title": "Phase II Study for the Evaluation of CPT-11 (Irinotecan, Camptosar) in Patients With Metastatic or Recurrent Breast Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically proven advanced breast cancer Must have received anthracycline and taxane based chemotherapy for metastatic disease Measurable disease No CNS metastases or carcinomatous meningitis Hormone receptor status: Not specified\n\nPATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count greater than 1500/mm3 Hemoglobin at least 9.0 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.3 mg/dL SGOT no greater than 3 times upper limit of normal (no greater than 5 times ULN if liver involvement) No Gilbert's disease Renal: Creatinine no greater than 2.0 mg/dL Calcium at least 12.0 mg/dL Cardiovascular: No myocardial infarction in the past 6 months No congestive heart failure requiring therapy Other: No active or uncontrolled infection HIV negative No psychiatric disorder that would preclude study No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No history of seizures No uncontrolled diabetes mellitus (random blood sugar at least 200 mg) No other severe disease that would preclude study Not pregnant or nursing Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Greater than 4 weeks since prior chemotherapy No prior irinotecan or topotecan Endocrine therapy: Not specified Radiotherapy: Greater than 4 weeks since prior radiotherapy No radiotherapy to greater than 30% of bone marrow Surgery: Not specified Other: No concurrent phenytoin, phenobarbitol, or other antiepileptic prophylaxis"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS: Histologically proven advanced breast cancer Must have received anthracycline and taxane based chemotherapy for metastatic disease Measurable disease No CNS metastases or carcinomatous meningitis Hormone receptor status: Not specified",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven advanced breast cancer",
                    "criterion": "advanced breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "Must have received anthracycline and taxane based chemotherapy for metastatic disease",
                    "criterion": "chemotherapy for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "anthracycline",
                                "taxane"
                            ]
                        },
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No CNS metastases or carcinomatous meningitis",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No CNS metastases or carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hormone receptor status: Not specified",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "Not specified"
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Greater than 4 weeks since prior chemotherapy No prior irinotecan or topotecan Endocrine therapy: Not specified Radiotherapy: Greater than 4 weeks since prior radiotherapy No radiotherapy to greater than 30% of bone marrow Surgery: Not specified Other: No concurrent phenytoin, phenobarbitol, or other antiepileptic prophylaxis",
            "criterions": [
                {
                    "exact_snippets": "Greater than 4 weeks since prior chemotherapy",
                    "criterion": "time since prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior irinotecan or topotecan",
                    "criterion": "prior irinotecan or topotecan",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Greater 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": "No radiotherapy to greater than 30% of bone marrow",
                    "criterion": "radiotherapy to bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent phenytoin, phenobarbitol, or other antiepileptic prophylaxis",
                    "criterion": "concurrent antiepileptic prophylaxis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count greater than 1500/mm3 Hemoglobin at least 9.0 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.3 mg/dL SGOT no greater than 3 times upper limit of normal (no greater than 5 times ULN if liver involvement) No Gilbert's disease Renal: Creatinine no greater than 2.0 mg/dL Calcium at least 12.0 mg/dL Cardiovascular: No myocardial infarction in the past 6 months No congestive heart failure requiring therapy Other: No active or uncontrolled infection HIV negative No psychiatric disorder that would preclude study No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No history of seizures No uncontrolled diabetes mellitus (random blood sugar at least 200 mg) No other severe disease that would preclude study Not pregnant or nursing Fertile patients must use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Age: 18 and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Menopausal status: Not specified",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "Not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: ECOG 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "ECOG"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Life expectancy: At least 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: Granulocyte count greater than 1500/mm3",
                    "criterion": "granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: ... Hemoglobin at least 9.0 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: ... Platelet count greater than 100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic: Bilirubin no greater than 1.3 mg/dL",
                    "criterion": "bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.3,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic: ... SGOT no greater than 3 times upper limit of normal (no greater than 5 times ULN if liver involvement)",
                    "criterion": "SGOT",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": "3 times ULN"
                        },
                        {
                            "requirement_type": "maximum with condition",
                            "expected_value": "5 times ULN if liver involvement"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic: ... No Gilbert's disease",
                    "criterion": "Gilbert's disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal: Creatinine no greater than 2.0 mg/dL",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal: ... Calcium at least 12.0 mg/dL",
                    "criterion": "calcium",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiovascular: No myocardial infarction in the past 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": "no in past 6 months"
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiovascular: No congestive heart failure requiring therapy",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not requiring therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: No active or uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "no active or uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: HIV negative",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: No psychiatric disorder that would preclude study",
                    "criterion": "psychiatric disorder",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "not precluding study"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": "no in past 5 years"
                        },
                        {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "adequately treated basal cell or squamous cell skin cancer",
                                "carcinoma in situ of the cervix"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: No history of seizures",
                    "criterion": "history of seizures",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: No uncontrolled diabetes mellitus (random blood sugar at least 200 mg)",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        },
                        {
                            "requirement_type": "random blood sugar",
                            "expected_value": {
                                "operator": ">=",
                                "value": 200,
                                "unit": "mg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: No other severe disease that would preclude study",
                    "criterion": "severe disease",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "not precluding study"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: Not pregnant or nursing",
                    "criterion": "pregnancy or nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not pregnant or nursing"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: Fertile patients must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": "must use effective contraception"
                        }
                    ]
                }
            ]
        }
    ]
}