{
    "info": {
        "nct_id": "NCT00494182",
        "official_title": "A Phase II Study of Sorafenib in Combination With Carboplatin and Paclitaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer",
        "inclusion_criteria": "* Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.\n* Patients must have cytologically or histologically proven recurrent or metastatic squamous cell cancer of the head and neck (SCCHN) from the primary tumor or lymph nodes of the oral cavity, larynx, oropharynx, or hypopharynx.\n* No prior systemic chemotherapy for patients who present with metastatic disease. For patients with recurrent head and neck squamous cell carcinoma, prior chemotherapy is allowed if it was given as part of their definitive therapy. If patients have received prior combined modality therapy, they must be off therapy for at least 6 months.\n* Patients must have at least 1 evaluable lesion. Lesions must be evaluated by computed Tomography (CT) scan or magnetic resonance imaging (MRI).\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.\n* Controlled blood pressure (defined as systolic blood pressure [BP] =< 140 mmHg and diastolic =< 85 mmHg).\n* Hemoglobin >= 9.0 g/dL within 7 days prior to start of first dose.\n* Absolute neutrophil count (ANC) >= 1,500/mm^3 within 7 days prior to start of first dose.\n* Platelet count >= 100,000/mm^3 within 7 days prior to start of first dose.\n* Total bilirubin =< 1.5 times the upper limit of normal (ULN) within 7 days prior to start of first dose.\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5 x ULN for patients [pts] with [w/] liver involvement) within 7 days prior to start of first dose.\n* International normalized ratio (INR) =< 1.5 and partial thromboplastin time (PTT) within (w/in) normal limits within 7 days prior to start of first dose.\n* Serum creatinine =< 1.5 ULN or creatinine clearance (CrCl) >= 45 mL/min for patients (pts) w/ creatinine levels above institutional normal within 7 days prior to start of first dose.\n* Amylase & lipase < 1.5 x the ULN within 7 days prior to start of first dose.\n* Urinalysis (UA) must show less than 1+ protein in urine, or the pt will require a repeat UA. If repeat UA shows 1+ protein or more, a 24 hour urine collection will be required & must show total protein =< 1000 mg/24 hour to be eligible.\n* Women of childbearing potential (not surgically sterilized or at least 2 years postmenopausal) must have a negative serum or urine pregnancy test performed within 7 days prior to the start of treatment.\n* Women of childbearing potential and men must agree to use adequate contraception (abstinence; hormonal or barrier method of birth control) prior to study entry, for the duration of study participation and 3 months after end of treatment. Should a woman become pregnant while participating or the partner of a patient participating in this study becomes pregnant, they should inform their treating physician immediately.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Congestive heart failure (CHF) > class II New York Heart Association (NYHA); active coronary artery disease (myocardial infarction [MI] more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).\n* Uncontrolled hypertension defined as systolic blood pressure > 140 mmHg or diastolic pressure > 85 mmHg despite optimal medical management.\n* Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.\n* Active clinically serious infections (i.e. patients currently taking antibiotics) (grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events (CTCAE) version 3.0).\n* Evidence or history of central nervous system (CNS) disease, including primary brain tumors, seizures disorders, or any brain metastasis.\n* Thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism. History of transient ischemic attack is allowed.\n* Evidence or history of bleeding diathesis or coagulopathy.\n* History of/or current evidence of hemoptysis (bright red blood of ½ teaspoon or more).\n* Peripheral neuropathy >= grade 2 (NCI-CTC version 3.0).\n* Anticancer chemotherapy or immunotherapy: anticancer therapy is defined as any agent or combination of agents with clinically proven anticancer activity administered by any route with the purpose of affecting the cancer, either directly or indirectly, including palliative and therapeutic endpoints.\n* Radiotherapy to the target lesions within 3 weeks of start of first dose. Toxicities from radiotherapy must have resolved prior to start of first dose.\n* No major surgery, open biopsy or significant traumatic injury within 4 weeks of start of first dose.\n* Serious, non-healing wound, ulcer, or bone fracture.\n* Granulocyte growth factors (G-CSF), within 3 weeks of study entry.\n* Patients taking chronic erythropoietin are permitted provided no dose adjustment is made within 2 months prior to start of first dose.\n* Pregnant or breastfeeding patients.\n* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.\n* Known or suspected allergy to any recombinant human antibodies, or compounds of similar chemical or biologic composition to sorafenib or any of the drugs in this study.\n* Any condition that is unstable or could jeopardize the safety or compliance of the patient in the study.\n* Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in the study EXCEPT cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1) or any cancer curatively treated > 3 years prior to study entry.\n* Known or suspected allergy to sorafenib (BAY 43-9006) or any agent given in association with this trial.\n* Any malabsorption conditions.\n* Therapeutic anticoagulation with warfarin, heparins, or heparinoids.\n* Patients taking phenytoin, carbamazepine, and phenobarbital.\n* Patients taking rifampin and/or St. John's Wort.\n* Patients who are candidates for curative surgery or radiotherapy.\n* The patient has progressed within 6 months after completion of curative intent (definitive) treatment for localized/locoregionally advanced disease.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have cytologically or histologically proven recurrent or metastatic squamous cell cancer of the head and neck (SCCHN) from the primary tumor or lymph nodes of the oral cavity, larynx, oropharynx, or hypopharynx.",
            "criterions": [
                {
                    "exact_snippets": "cytologically or histologically proven",
                    "criterion": "cancer diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "cytologically",
                                "histologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent or metastatic squamous cell cancer of the head and neck (SCCHN)",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "recurrent or metastatic squamous cell cancer of the head and neck (SCCHN)"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary tumor or lymph nodes of the oral cavity, larynx, oropharynx, or hypopharynx",
                    "criterion": "cancer location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "primary tumor",
                                "lymph nodes of the oral cavity",
                                "larynx",
                                "oropharynx",
                                "hypopharynx"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior systemic chemotherapy for patients who present with metastatic disease. For patients with recurrent head and neck squamous cell carcinoma, prior chemotherapy is allowed if it was given as part of their definitive therapy. If patients have received prior combined modality therapy, they must be off therapy for at least 6 months.",
            "criterions": [
                {
                    "exact_snippets": "No prior systemic chemotherapy for patients who present with metastatic disease.",
                    "criterion": "prior systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "For patients with recurrent head and neck squamous cell carcinoma, prior chemotherapy is allowed if it was given as part of their definitive therapy.",
                    "criterion": "prior chemotherapy for recurrent head and neck squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "context",
                            "expected_value": "allowed if given as part of definitive therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "If patients have received prior combined modality therapy, they must be off therapy for at least 6 months.",
                    "criterion": "prior combined modality therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have at least 1 evaluable lesion. Lesions must be evaluated by computed Tomography (CT) scan or magnetic resonance imaging (MRI).",
            "criterions": [
                {
                    "exact_snippets": "Patients must have at least 1 evaluable lesion.",
                    "criterion": "evaluable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Lesions must be evaluated by computed Tomography (CT) scan or magnetic resonance imaging (MRI).",
                    "criterion": "lesion evaluation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "computed Tomography (CT) scan",
                                "magnetic resonance imaging (MRI)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Controlled blood pressure (defined as systolic blood pressure [BP] =< 140 mmHg and diastolic =< 85 mmHg).",
            "criterions": [
                {
                    "exact_snippets": "Controlled blood pressure (defined as systolic blood pressure [BP] =< 140 mmHg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 140,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Controlled blood pressure ... diastolic =< 85 mmHg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 85,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin >= 9.0 g/dL within 7 days prior to start of first dose.",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin >= 9.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days prior to start of first dose",
                    "criterion": "timeframe for hemoglobin test",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 7 days prior to start of first dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) >= 1,500/mm^3 within 7 days prior to start of first dose.",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) >= 1,500/mm^3",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count >= 100,000/mm^3 within 7 days prior to start of first dose.",
            "criterions": [
                {
                    "exact_snippets": "Platelet count >= 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin =< 1.5 times the upper limit of normal (ULN) within 7 days prior to start of first dose.",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin =< 1.5 times the upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times the upper limit of normal (ULN)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* International normalized ratio (INR) =< 1.5 and partial thromboplastin time (PTT) within (w/in) normal limits within 7 days prior to start of first dose.",
            "criterions": [
                {
                    "exact_snippets": "International normalized ratio (INR) =< 1.5",
                    "criterion": "International normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "partial thromboplastin time (PTT) within (w/in) normal limits",
                    "criterion": "partial thromboplastin time (PTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "within normal limits"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days prior to start of first dose",
                    "criterion": "timeframe for tests",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 7 days prior to start of first dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine =< 1.5 ULN or creatinine clearance (CrCl) >= 45 mL/min for patients (pts) w/ creatinine levels above institutional normal within 7 days prior to start of first dose.",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine =< 1.5 ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance (CrCl) >= 45 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Amylase & lipase < 1.5 x the ULN within 7 days prior to start of first dose.",
            "criterions": [
                {
                    "exact_snippets": "Amylase ... < 1.5 x the ULN within 7 days prior to start of first dose.",
                    "criterion": "amylase level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lipase < 1.5 x the ULN within 7 days prior to start of first dose.",
                    "criterion": "lipase level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Urinalysis (UA) must show less than 1+ protein in urine, or the pt will require a repeat UA. If repeat UA shows 1+ protein or more, a 24 hour urine collection will be required & must show total protein =< 1000 mg/24 hour to be eligible.",
            "criterions": [
                {
                    "exact_snippets": "Urinalysis (UA) must show less than 1+ protein in urine",
                    "criterion": "protein in urine (initial UA)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "repeat UA shows 1+ protein or more",
                    "criterion": "protein in urine (repeat UA)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "24 hour urine collection ... must show total protein =< 1000 mg/24 hour",
                    "criterion": "total protein in 24 hour urine collection",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1000,
                                "unit": "mg/24 hour"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential (not surgically sterilized or at least 2 years postmenopausal) must have a negative serum or urine pregnancy test performed within 7 days prior to the start of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential (not surgically sterilized or at least 2 years postmenopausal)",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative serum or urine pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "performed within 7 days prior to the start of treatment",
                    "criterion": "timing of pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to the start of treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential and men must agree to use adequate contraception (abstinence; hormonal or barrier method of birth control) prior to study entry, for the duration of study participation and 3 months after end of treatment. Should a woman become pregnant while participating or the partner of a patient participating in this study becomes pregnant, they should inform their treating physician immediately.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "men must agree to use adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abstinence; hormonal or barrier method of birth control",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "abstinence",
                                "hormonal",
                                "barrier"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "prior to study entry, for the duration of study participation and 3 months after end of treatment",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "time period",
                            "expected_value": "prior to study entry, for the duration of study participation and 3 months after end of treatment"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Congestive heart failure (CHF) > class II New York Heart Association (NYHA); active coronary artery disease (myocardial infarction [MI] more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).",
            "criterions": [
                {
                    "exact_snippets": "Congestive heart failure (CHF) > class II New York Heart Association (NYHA)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "NYHA class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "active coronary artery disease",
                    "criterion": "coronary artery disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction [MI] more than 6 months prior to study entry is allowed",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy",
                    "criterion": "cardiac ventricular arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension defined as systolic blood pressure > 140 mmHg or diastolic pressure > 85 mmHg despite optimal medical management.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension defined as systolic blood pressure > 140 mmHg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 140,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled hypertension defined as ... diastolic pressure > 85 mmHg",
                    "criterion": "diastolic pressure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 85,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled hypertension ... despite optimal medical management",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active clinically serious infections (i.e. patients currently taking antibiotics) (grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events (CTCAE) version 3.0).",
            "criterions": [
                {
                    "exact_snippets": "Active clinically serious infections (i.e. patients currently taking antibiotics)",
                    "criterion": "active clinically serious infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events (CTCAE) version 3.0",
                    "criterion": "infection severity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "grade 2"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence or history of central nervous system (CNS) disease, including primary brain tumors, seizures disorders, or any brain metastasis.",
            "criterions": [
                {
                    "exact_snippets": "Evidence or history of central nervous system (CNS) disease",
                    "criterion": "central nervous system (CNS) disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "primary brain tumors",
                    "criterion": "primary brain tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "seizures disorders",
                    "criterion": "seizure disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism. History of transient ischemic attack is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism.",
                    "criterion": "thrombotic or embolic events",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "History of transient ischemic attack is allowed.",
                    "criterion": "transient ischemic attack",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence or history of bleeding diathesis or coagulopathy.",
            "criterions": [
                {
                    "exact_snippets": "Evidence or history of bleeding diathesis",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence or history of ... coagulopathy",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of/or current evidence of hemoptysis (bright red blood of ½ teaspoon or more).",
            "criterions": [
                {
                    "exact_snippets": "History of/or current evidence of hemoptysis",
                    "criterion": "hemoptysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "bright red blood of ½ teaspoon or more",
                    "criterion": "hemoptysis severity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0.5,
                                "unit": "teaspoon"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Peripheral neuropathy >= grade 2 (NCI-CTC version 3.0).",
            "criterions": [
                {
                    "exact_snippets": "Peripheral neuropathy >= grade 2 (NCI-CTC version 3.0)",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Anticancer chemotherapy or immunotherapy: anticancer therapy is defined as any agent or combination of agents with clinically proven anticancer activity administered by any route with the purpose of affecting the cancer, either directly or indirectly, including palliative and therapeutic endpoints.",
            "criterions": [
                {
                    "exact_snippets": "Anticancer chemotherapy or immunotherapy: anticancer therapy is defined as any agent or combination of agents with clinically proven anticancer activity",
                    "criterion": "anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiotherapy to the target lesions within 3 weeks of start of first dose. Toxicities from radiotherapy must have resolved prior to start of first dose.",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy to the target lesions within 3 weeks of start of first dose.",
                    "criterion": "radiotherapy timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Toxicities from radiotherapy must have resolved prior to start of first dose.",
                    "criterion": "radiotherapy toxicities",
                    "requirements": [
                        {
                            "requirement_type": "resolution",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No major surgery, open biopsy or significant traumatic injury within 4 weeks of start of first dose.",
            "criterions": [
                {
                    "exact_snippets": "No major surgery ... within 4 weeks of start of first dose.",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... open biopsy ... within 4 weeks of start of first dose.",
                    "criterion": "open biopsy",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... significant traumatic injury within 4 weeks of start of first dose.",
                    "criterion": "significant traumatic injury",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious, non-healing wound, ulcer, or bone fracture.",
            "criterions": [
                {
                    "exact_snippets": "Serious, non-healing wound",
                    "criterion": "wound",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious, non-healing ... ulcer",
                    "criterion": "ulcer",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious, non-healing ... bone fracture",
                    "criterion": "bone fracture",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Granulocyte growth factors (G-CSF), within 3 weeks of study entry.",
            "criterions": [
                {
                    "exact_snippets": "Granulocyte growth factors (G-CSF), within 3 weeks of study entry.",
                    "criterion": "granulocyte growth factors (G-CSF)",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients taking chronic erythropoietin are permitted provided no dose adjustment is made within 2 months prior to start of first dose.",
            "criterions": [
                {
                    "exact_snippets": "Patients taking chronic erythropoietin",
                    "criterion": "chronic erythropoietin use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no dose adjustment is made within 2 months prior to start of first dose",
                    "criterion": "erythropoietin dose adjustment",
                    "requirements": [
                        {
                            "requirement_type": "time since last adjustment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breastfeeding patients.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.",
            "criterions": [
                {
                    "exact_snippets": "Substance abuse",
                    "criterion": "substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "medical ... conditions that may interfere with the patient's participation in the study or evaluation of the study results",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "interference with study participation or evaluation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "psychological ... conditions that may interfere with the patient's participation in the study or evaluation of the study results",
                    "criterion": "psychological conditions",
                    "requirements": [
                        {
                            "requirement_type": "interference with study participation or evaluation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "social conditions that may interfere with the patient's participation in the study or evaluation of the study results",
                    "criterion": "social conditions",
                    "requirements": [
                        {
                            "requirement_type": "interference with study participation or evaluation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known or suspected allergy to any recombinant human antibodies, or compounds of similar chemical or biologic composition to sorafenib or any of the drugs in this study.",
            "criterions": [
                {
                    "exact_snippets": "Known or suspected allergy to any recombinant human antibodies",
                    "criterion": "allergy to recombinant human antibodies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allergy to any ... compounds of similar chemical or biologic composition to sorafenib",
                    "criterion": "allergy to compounds similar to sorafenib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allergy to any ... drugs in this study",
                    "criterion": "allergy to drugs in this study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any condition that is unstable or could jeopardize the safety or compliance of the patient in the study.",
            "criterions": [
                {
                    "exact_snippets": "Any condition that is unstable",
                    "criterion": "condition stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "condition that ... could jeopardize the safety",
                    "criterion": "condition impact on safety",
                    "requirements": [
                        {
                            "requirement_type": "impact on safety",
                            "expected_value": "jeopardizing"
                        }
                    ]
                },
                {
                    "exact_snippets": "condition that ... could jeopardize ... compliance",
                    "criterion": "condition impact on compliance",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "jeopardizing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in the study EXCEPT cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1) or any cancer curatively treated > 3 years prior to study entry.",
            "criterions": [
                {
                    "exact_snippets": "Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in the study",
                    "criterion": "previous or concurrent cancer",
                    "requirements": [
                        {
                            "requirement_type": "distinctness",
                            "expected_value": "distinct in primary site or histology from the cancer being evaluated in the study"
                        }
                    ]
                },
                {
                    "exact_snippets": "EXCEPT cervical cancer in situ",
                    "criterion": "cervical cancer in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "EXCEPT ... treated basal cell carcinoma",
                    "criterion": "treated basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "EXCEPT ... superficial bladder tumors (Ta, Tis and T1)",
                    "criterion": "superficial bladder tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "EXCEPT ... any cancer curatively treated > 3 years prior to study entry",
                    "criterion": "cancer curatively treated",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known or suspected allergy to sorafenib (BAY 43-9006) or any agent given in association with this trial.",
            "criterions": [
                {
                    "exact_snippets": "Known or suspected allergy to sorafenib (BAY 43-9006)",
                    "criterion": "allergy to sorafenib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "allergy to ... any agent given in association with this trial",
                    "criterion": "allergy to trial-associated agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any malabsorption conditions.",
            "criterions": [
                {
                    "exact_snippets": "Any malabsorption conditions",
                    "criterion": "malabsorption conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Therapeutic anticoagulation with warfarin, heparins, or heparinoids.",
            "criterions": [
                {
                    "exact_snippets": "Therapeutic anticoagulation with warfarin, heparins, or heparinoids.",
                    "criterion": "therapeutic anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": [
                                "warfarin",
                                "heparins",
                                "heparinoids"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients taking phenytoin, carbamazepine, and phenobarbital.",
            "criterions": [
                {
                    "exact_snippets": "Patients taking phenytoin",
                    "criterion": "phenytoin use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients taking ... carbamazepine",
                    "criterion": "carbamazepine use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients taking ... phenobarbital",
                    "criterion": "phenobarbital use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients taking rifampin and/or St. John's Wort.",
            "criterions": [
                {
                    "exact_snippets": "Patients taking rifampin",
                    "criterion": "rifampin use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients taking ... St. John's Wort",
                    "criterion": "St. John's Wort use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are candidates for curative surgery or radiotherapy.",
            "criterions": [
                {
                    "exact_snippets": "candidates for curative surgery",
                    "criterion": "curative surgery candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "candidates for ... radiotherapy",
                    "criterion": "radiotherapy candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has progressed within 6 months after completion of curative intent (definitive) treatment for localized/locoregionally advanced disease.",
            "criterions": [
                {
                    "exact_snippets": "The patient has progressed within 6 months after completion of curative intent (definitive) treatment",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "curative intent (definitive) treatment for localized/locoregionally advanced disease",
                    "criterion": "treatment type",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "localized",
                                "locoregionally advanced"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5 x ULN for patients [pts] with [w/] liver involvement) within 7 days prior to start of first dose.",
            "criterions": [
                {
                    "exact_snippets": "Alanine aminotransferase (ALT) ... =< 2.5 x ULN (=< 5 x ULN for patients [pts] with [w/] liver involvement)",
                    "criterion": "Alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5 x ULN for patients [pts] with [w/] liver involvement)",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alanine aminotransferase (ALT) ... =< 5 x ULN for patients [pts] with [w/] liver involvement",
                    "criterion": "Alanine aminotransferase (ALT) with liver involvement",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) =< 5 x ULN for patients [pts] with [w/] liver involvement",
                    "criterion": "aspartate aminotransferase (AST) with liver involvement",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days prior to start of first dose",
                    "criterion": "timeframe for ALT and AST measurement",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 7 days prior to start of first dose"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [
        {
            "line": "* Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.",
            "criterions": [
                {
                    "exact_snippets": "Known history of human immunodeficiency virus (HIV) infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic hepatitis B",
                    "criterion": "chronic hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic hepatitis C",
                    "criterion": "chronic hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}