{
    "info": {
        "nct_id": "NCT00003548",
        "official_title": "Phase I Study of Intraperitoneal Administration of 9-Amino-20(S)-Camptothecin to Patients With Cancer Predominantly Confined to the Peritoneal Cavity",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed advanced malignancy involving the peritoneal cavity, excluding leukemia and lymphoma Patients with ovarian cancer must have received prior standard therapy Predominantly small tumor metastases less than 1.0 cm in diameter including: Ovarian cancer with epithelial histology Other gynecological tumors Breast cancer Gastric cancer Colorectal cancer Appendiceal cancer Pancreatic cancer Unknown primary cancer Other malignancies with predominantly intraperitoneal manifestation No extensive intraperitoneal adhesions that cannot be easily lysed laparoscopically or by laparotomy No symptomatic disease outside the peritoneal cavity Asymptomatic disease outside the peritoneum considered (e.g., bone lesions)\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST no greater than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and/or mitomycin) Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: See Disease Characteristics"
    },
    "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 malignancy involving the peritoneal cavity, excluding leukemia and lymphoma Patients with ovarian cancer must have received prior standard therapy Predominantly small tumor metastases less than 1.0 cm in diameter including: Ovarian cancer with epithelial histology Other gynecological tumors Breast cancer Gastric cancer Colorectal cancer Appendiceal cancer Pancreatic cancer Unknown primary cancer Other malignancies with predominantly intraperitoneal manifestation No extensive intraperitoneal adhesions that cannot be easily lysed laparoscopically or by laparotomy No symptomatic disease outside the peritoneal cavity Asymptomatic disease outside the peritoneum considered (e.g., bone lesions)",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed advanced malignancy involving the peritoneal cavity",
                    "criterion": "advanced malignancy",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically"
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": "peritoneal cavity"
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding leukemia and lymphoma",
                    "criterion": "disease type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "leukemia",
                                "lymphoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with ovarian cancer must have received prior standard therapy",
                    "criterion": "ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "prior therapy",
                            "expected_value": "standard therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Predominantly small tumor metastases less than 1.0 cm in diameter",
                    "criterion": "tumor metastases",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.0,
                                "unit": "cm"
                            }
                        },
                        {
                            "requirement_type": "predominance",
                            "expected_value": "small"
                        }
                    ]
                },
                {
                    "exact_snippets": "Ovarian cancer with epithelial histology",
                    "criterion": "ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "histology",
                            "expected_value": "epithelial"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other gynecological tumors",
                    "criterion": "gynecological tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Gastric cancer",
                    "criterion": "gastric cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Colorectal cancer",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Appendiceal cancer",
                    "criterion": "appendiceal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Unknown primary cancer",
                    "criterion": "unknown primary cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Other malignancies with predominantly intraperitoneal manifestation",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "manifestation",
                            "expected_value": "predominantly intraperitoneal"
                        }
                    ]
                },
                {
                    "exact_snippets": "No extensive intraperitoneal adhesions that cannot be easily lysed laparoscopically or by laparotomy",
                    "criterion": "intraperitoneal adhesions",
                    "requirements": [
                        {
                            "requirement_type": "extensiveness",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "lysis",
                            "expected_value": "easily lysed laparoscopically or by laparotomy"
                        }
                    ]
                },
                {
                    "exact_snippets": "No symptomatic disease outside the peritoneal cavity",
                    "criterion": "symptomatic disease outside the peritoneal cavity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Asymptomatic disease outside the peritoneum considered (e.g., bone lesions)",
                    "criterion": "asymptomatic disease outside the peritoneum",
                    "requirements": [
                        {
                            "requirement_type": "consideration",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST no greater than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Age: 18 and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: ECOG 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "ECOG"
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Life expectancy: At least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "minimum duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: Neutrophil count at least 1,500/mm3",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "minimum count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count at least 100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "minimum count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic: Bilirubin no greater than 2.0 mg/dL",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "maximum level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST no greater than 2 times upper limit of normal",
                    "criterion": "AST level",
                    "requirements": [
                        {
                            "requirement_type": "maximum level",
                            "expected_value": "2 times upper limit of normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal: Creatinine no greater than 2.0 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "maximum level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Not pregnant or nursing",
                    "criterion": "pregnancy or nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Fertile patients must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and/or mitomycin) Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "At least 3 weeks since prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "6 weeks for nitrosoureas and/or mitomycin",
                    "criterion": "prior nitrosoureas and/or mitomycin chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 3 weeks since prior radiotherapy",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}