{
"info": {
"nct_id": "NCT00003072",
"official_title": "Amifostine (Ethyol) as a Protectant in Metastatic Ovarian and Non-Small Cell Lung Cancer in Paclitaxel/Carboplatin-Treated Patients: A Comparative Trial",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically proven stage III/IV ovarian or non-small cell lung cancer\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-2 Life Expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 3.0 mg/dL Renal: Creatinine no greater than 2 mg/dL Other: Not pregnant or nursing No history of platinum, paclitaxel or amifostine hypersensitivity Prior myelosuppressive events allowed No clinically significant ascites\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy within 1 month of study Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy within 1 month of study Surgery: Not specified"
},
"inclusion_lines": [
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"line": "DISEASE CHARACTERISTICS: Histologically proven stage III/IV ovarian or non-small cell lung cancer",
"criterions": [
{
"exact_snippets": "Histologically proven",
"criterion": "histological proof",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "stage III/IV",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"III",
"IV"
]
}
]
},
{
"exact_snippets": "ovarian or non-small cell lung cancer",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"ovarian",
"non-small cell lung"
]
}
]
}
]
},
{
"line": "PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-2 Life Expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 3.0 mg/dL Renal: Creatinine no greater than 2 mg/dL Other: Not pregnant or nursing No history of platinum, paclitaxel or amifostine hypersensitivity Prior myelosuppressive events allowed No clinically significant ascites",
"criterions": [
{
"exact_snippets": "Age: 18 and over",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": true
}
]
},
{
"exact_snippets": "Performance Status: ECOG 0-2",
"criterion": "performance status",
"requirements": [
{
"requirement_type": "ECOG score",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
]
},
{
"exact_snippets": "Absolute neutrophil count at least 1,500/mm3",
"criterion": "absolute neutrophil count",
"requirements": [
{
"requirement_type": "minimum count",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm3"
}
}
]
},
{
"exact_snippets": "Platelet count at least 100,000/mm3",
"criterion": "platelet count",
"requirements": [
{
"requirement_type": "minimum count",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm3"
}
}
]
},
{
"exact_snippets": "Bilirubin no greater than 3.0 mg/dL",
"criterion": "bilirubin level",
"requirements": [
{
"requirement_type": "maximum level",
"expected_value": {
"operator": "<=",
"value": 3.0,
"unit": "mg/dL"
}
}
]
},
{
"exact_snippets": "Creatinine no greater than 2 mg/dL",
"criterion": "creatinine level",
"requirements": [
{
"requirement_type": "maximum level",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "mg/dL"
}
}
]
},
{
"exact_snippets": "Not pregnant or nursing",
"criterion": "pregnancy or nursing status",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
},
{
"exact_snippets": "No history of platinum, paclitaxel or amifostine hypersensitivity",
"criterion": "hypersensitivity history",
"requirements": [
{
"requirement_type": "medications",
"expected_value": [
"platinum",
"paclitaxel",
"amifostine"
]
}
]
},
{
"exact_snippets": "Prior myelosuppressive events allowed",
"criterion": "prior myelosuppressive events",
"requirements": [
{
"requirement_type": "allowance",
"expected_value": true
}
]
},
{
"exact_snippets": "No clinically significant ascites",
"criterion": "clinically significant ascites",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy within 1 month of study Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy within 1 month of study Surgery: Not specified",
"criterions": [
{
"exact_snippets": "No prior chemotherapy within 1 month of study",
"criterion": "prior chemotherapy",
"requirements": [
{
"requirement_type": "time since last treatment",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "month"
}
}
]
},
{
"exact_snippets": "No prior radiation therapy within 1 month of study",
"criterion": "prior radiation therapy",
"requirements": [
{
"requirement_type": "time since last treatment",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "month"
}
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}