{
    "info": {
        "nct_id": "NCT00003360",
        "official_title": "Phase I Study of 131I-Labeled Humanized Antibody A33 in Patients With Advanced Colorectal Carcinoma",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed advanced colorectal cancer Must have unresectable (Stage IV) disease or have failed or refused conventional chemotherapy Measurable disease by conventional imaging methods Liver involvement no greater than 50% No CNS involvement Not positive for human antimouse antibody titer\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 150,000/mm3 Prothrombin time less than 1.3 times control Hepatic: Bilirubin no greater than 1 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No significant cardiac disease (New York Heart Association class II/IV heart disease) Other: No serious infection requiring treatment with antibiotics No other serious illness Not pregnant or nursing Effective contraception required of all fertile patients\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No prior mouse monoclonal antibody or antibody fragment, chimeric or humanized antibody, or constructs derived from antibodies At least 4 weeks since prior immunotherapy Chemotherapy: No prior mitomycin/radiotherapy combination At least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent steroids or other antiinflammatory agents Radiotherapy: No prior radiotherapy/mitomycin combination Surgery: Not specified"
    },
    "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 confirmed advanced colorectal cancer Must have unresectable (Stage IV) disease or have failed or refused conventional chemotherapy Measurable disease by conventional imaging methods Liver involvement no greater than 50% No CNS involvement Not positive for human antimouse antibody titer",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed advanced colorectal cancer",
                    "criterion": "advanced colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable (Stage IV) disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "Stage IV"
                        },
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "failed or refused conventional chemotherapy",
                    "criterion": "conventional chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "failed",
                                "refused"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Measurable disease by conventional imaging methods",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "measurement method",
                            "expected_value": "conventional imaging methods"
                        }
                    ]
                },
                {
                    "exact_snippets": "Liver involvement no greater than 50%",
                    "criterion": "liver involvement",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": "<=",
                                "value": 50,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No CNS involvement",
                    "criterion": "CNS involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Not positive for human antimouse antibody titer",
                    "criterion": "human antimouse antibody titer",
                    "requirements": [
                        {
                            "requirement_type": "positivity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 150,000/mm3 Prothrombin time less than 1.3 times control Hepatic: Bilirubin no greater than 1 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No significant cardiac disease (New York Heart Association class II/IV heart disease) Other: No serious infection requiring treatment with antibiotics No other serious illness Not pregnant or nursing Effective contraception required of all fertile patients",
            "criterions": [
                {
                    "exact_snippets": "Age: 18 and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: Karnofsky 80-100%",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "Karnofsky"
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 80,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Life expectancy: At least 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: WBC at least 3,500/mm3",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count at least 150,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 150000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prothrombin time less than 1.3 times control",
                    "criterion": "prothrombin time",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.3,
                                "unit": "times control"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic: Bilirubin no greater than 1 mg/dL",
                    "criterion": "bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal: Creatinine no greater than 1.5 mg/dL",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiovascular: No significant cardiac disease (New York Heart Association class II/IV heart disease)",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "classification",
                            "expected_value": "New York Heart Association class II/IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: No serious infection requiring treatment with antibiotics",
                    "criterion": "serious infection",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "antibiotics"
                        }
                    ]
                },
                {
                    "exact_snippets": "No other serious illness",
                    "criterion": "serious illness",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Not pregnant or nursing",
                    "criterion": "pregnancy or nursing",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Effective contraception required of all fertile patients",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "effective"
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: No prior mouse monoclonal antibody or antibody fragment, chimeric or humanized antibody, or constructs derived from antibodies At least 4 weeks since prior immunotherapy Chemotherapy: No prior mitomycin/radiotherapy combination At least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent steroids or other antiinflammatory agents Radiotherapy: No prior radiotherapy/mitomycin combination Surgery: Not specified",
            "criterions": [
                {
                    "exact_snippets": "No prior mouse monoclonal antibody or antibody fragment, chimeric or humanized antibody, or constructs derived from antibodies",
                    "criterion": "prior biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 4 weeks since prior immunotherapy",
                    "criterion": "time since prior immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior mitomycin/radiotherapy combination",
                    "criterion": "prior mitomycin/radiotherapy combination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 4 weeks since prior chemotherapy",
                    "criterion": "time since prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent steroids or other antiinflammatory agents",
                    "criterion": "concurrent endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior radiotherapy/mitomycin combination",
                    "criterion": "prior radiotherapy/mitomycin combination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}