{
    "info": {
        "nct_id": "NCT00593060",
        "official_title": "A Phase I Trial of Temsirolimus (CCI-779, Torisel) Combined With Cetuximab (Erbitux) in Cetuximab-Refractory Colorectal Cancer",
        "inclusion_criteria": "* Previously treated metastatic colorectal adenocarcinoma, histologically proven. Subjects must have previously received and had evidence of progression on cetuximab, bevacizumab, 5FU, irinotecan, and oxaliplatin, or demonstrated intolerance to those agents (except cetuximab).\n* Measurable disease by RECIST criteria\n* ECOG Performance Status 0 or 1.\n* Male or female, 18 years of age or older.\n* Life expectancy greater than or equal to 12 weeks.\n* At least 2 weeks have elapsed between previous anti-cancer therapy AND resolution of any skin rash related to prior treatment with an epidermal growth factor receptor inhibitor.\n* Lab values within ranges as outlined in protocol\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Diagnosis of second malignancy within the last 3 years, except for adequately treated basal cell carcinoma or squamous cell skin cancer.\n* Ongoing cardiac dysrhythmias of NCI CTCAE grade >/=2, atrial fibrillation, QTc prolongation to >450msec for males and >470 msec for females.\n* Known immunodeficiency disorders or active infections requiring treatment\n* Pregnancy or breastfeeding\n* Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease\n* Prior radiation therapy or major surgery within 2 weeks of study entry\n* Prior radiation therapy to > 25% of the bone marrow\n* Treatment with other experimental or alternative therapies during the course of the trial\n* History of hypersensitivity to polysorbate or cetuximab",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Previously treated metastatic colorectal adenocarcinoma, histologically proven. Subjects must have previously received and had evidence of progression on cetuximab, bevacizumab, 5FU, irinotecan, and oxaliplatin, or demonstrated intolerance to those agents (except cetuximab).",
            "criterions": [
                {
                    "exact_snippets": "Previously treated metastatic colorectal adenocarcinoma, histologically proven.",
                    "criterion": "metastatic colorectal adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": "previously treated"
                        },
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects must have previously received and had evidence of progression on cetuximab, bevacizumab, 5FU, irinotecan, and oxaliplatin, or demonstrated intolerance to those agents (except cetuximab).",
                    "criterion": "treatment with cetuximab, bevacizumab, 5FU, irinotecan, and oxaliplatin",
                    "requirements": [
                        {
                            "requirement_type": "progression evidence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "intolerance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease by RECIST criteria",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease by RECIST criteria",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "RECIST criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG Performance Status 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance Status 0 or 1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male or female, 18 years of age or older.",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy greater than or equal to 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy greater than or equal to 12 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 2 weeks have elapsed between previous anti-cancer therapy AND resolution of any skin rash related to prior treatment with an epidermal growth factor receptor inhibitor.",
            "criterions": [
                {
                    "exact_snippets": "At least 2 weeks have elapsed between previous anti-cancer therapy",
                    "criterion": "time since previous anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "resolution of any skin rash related to prior treatment with an epidermal growth factor receptor inhibitor",
                    "criterion": "skin rash related to prior treatment with an epidermal growth factor receptor inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "resolution",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lab values within ranges as outlined in protocol",
            "criterions": [
                {
                    "exact_snippets": "Lab values within ranges",
                    "criterion": "lab values",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "as outlined in protocol"
                        }
                    ]
                }
            ]
        },
        {
            "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": [
        {
            "line": "* Diagnosis of second malignancy within the last 3 years, except for adequately treated basal cell carcinoma or squamous cell skin cancer.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of second malignancy within the last 3 years",
                    "criterion": "second malignancy",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for adequately treated basal cell carcinoma or squamous cell skin cancer",
                    "criterion": "basal cell carcinoma or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing cardiac dysrhythmias of NCI CTCAE grade >/=2, atrial fibrillation, QTc prolongation to >450msec for males and >470 msec for females.",
            "criterions": [
                {
                    "exact_snippets": "Ongoing cardiac dysrhythmias of NCI CTCAE grade >/=2",
                    "criterion": "cardiac dysrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "NCI CTCAE grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "atrial fibrillation",
                    "criterion": "atrial fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc prolongation to >450msec for males",
                    "criterion": "QTc prolongation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "msec"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc prolongation to ... >470 msec for females",
                    "criterion": "QTc prolongation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "msec"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known immunodeficiency disorders or active infections requiring treatment",
            "criterions": [
                {
                    "exact_snippets": "Known immunodeficiency disorders",
                    "criterion": "immunodeficiency disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active infections requiring treatment",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease",
            "criterions": [
                {
                    "exact_snippets": "Brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior radiation therapy or major surgery within 2 weeks of study entry",
            "criterions": [
                {
                    "exact_snippets": "Prior radiation therapy",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "major surgery within 2 weeks of study entry",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior radiation therapy to > 25% of the bone marrow",
            "criterions": [
                {
                    "exact_snippets": "Prior radiation therapy to > 25% of the bone marrow",
                    "criterion": "radiation therapy to bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment with other experimental or alternative therapies during the course of the trial",
            "criterions": [
                {
                    "exact_snippets": "Treatment with other experimental or alternative therapies",
                    "criterion": "treatment with experimental or alternative therapies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of hypersensitivity to polysorbate or cetuximab",
            "criterions": [
                {
                    "exact_snippets": "History of hypersensitivity to polysorbate",
                    "criterion": "hypersensitivity to polysorbate",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of hypersensitivity to ... cetuximab",
                    "criterion": "hypersensitivity to cetuximab",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}