{
"info": {
"nct_id": "NCT00005791",
"official_title": "Phase I Trial of Irinotecan, Cisplatin, and Fluorouracil in Patients With Advanced Solid Tumor Malignancies",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed solid tumor malignancy not amenable to curative surgery or chemoradiation No CNS metastases, carcinomatous meningitis, or interstitial pulmonary fibrosis\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases) No known Gilbert's disease Renal: Creatinine no greater than 1.5 mg/dL Calcium less than 12.0 mg/dL No symptomatic hypercalcemia Cardiovascular: No unstable angina No New York Heart Association class III or IV cardiac disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active or uncontrolled infection No history of seizure disorder No uncontrolled diabetes mellitus, defined as random blood sugar 250 mg/dL or greater\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior mantle irradiation, hemibody irradiation, or radiation to the pelvis or lumbar spine Surgery: See Disease Characteristics Other: No concurrent phenytoin, phenobarbital, or other antiepileptic medication No concurrent prochlorperazine on day of irinotecan administration No concurrent prophylactic loperamide"
},
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"exact_snippets": "minimum age of 18 Years",
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{
"exact_snippets": "No ... carcinomatous meningitis",
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"exact_snippets": "No ... interstitial pulmonary fibrosis",
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"criterions": [
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}
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}
}
},
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"requirement": {
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"expected_value": "not specified"
}
},
{
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"unit": "mm3"
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},
{
"exact_snippets": "Neutrophil count at least 1,500/mm3",
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"operator": ">=",
"value": 1500,
"unit": "mm3"
}
}
},
{
"exact_snippets": "Platelet count at least 100,000/mm3",
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"operator": ">=",
"value": 100000,
"unit": "mm3"
}
}
},
{
"exact_snippets": "Hepatic: Bilirubin no greater than 1.5 mg/dL",
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{
"exact_snippets": "AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases)",
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"exact_snippets": "AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases)",
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}
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{
"exact_snippets": "Renal: Creatinine no greater than 1.5 mg/dL",
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"operator": "<=",
"value": 1.5,
"unit": "mg/dL"
}
}
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{
"exact_snippets": "Calcium less than 12.0 mg/dL",
"criterion": "calcium",
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"requirement_type": "level",
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"value": 12.0,
"unit": "mg/dL"
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}
},
{
"exact_snippets": "No New York Heart Association class III or IV cardiac disease",
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"requirement": {
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],
"failed_inclusion": [],
"failed_exclusion": [],
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}