{
"info": {
"nct_id": "NCT00006229",
"official_title": "A Phase II/III Double Blind Randomized Trial of BMS-275291 vs. Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-small Cell Lung Cancer",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC)\n\n * Local or metastatic failure after surgery and/or radiotherapy allowed\n* Phase II only:\n\n * At least one measurable lesion\n\n * At least 20 mm by conventional techniques OR 10 mm by spiral CT scan\n* No known CNS metastases unless asymptomatic and at least 4 weeks since prior corticosteroid therapy\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 12 weeks\n\nHematopoietic:\n\n* Absolute granulocyte count at least 1,500/mm^3\n* Platelet count at least 100,000/mm^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* ALT no greater than 2 times ULN (5 times ULN for liver metastases)\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n\nCardiovascular:\n\n* No significant cardiac disease\n* No uncontrolled high blood pressure, unstable angina, congestive heart failure, second or third degree atrioventricular conduction defects, or ventricular arrhythmias requiring medication\n* No myocardial infarction within the past year\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No prior allergic reaction to drugs containing Cremophor EL\n* No serious active infection or other underlying medical condition that would preclude study participation\n* No peripheral neuropathy\n* No condition (e.g., psychological, geographical) that would preclude study participation\n* No prior breast cancer or melanoma\n* No other prior malignancy within the past 5 years except carcinoma in situ, basal cell or squamous cell skin cancer, or other cancer that has been curatively treated surgically\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior immunotherapy\n* No prior biological response modifiers\n* No other concurrent biologic therapy or immunotherapy\n\nChemotherapy:\n\n* No prior antineoplastic chemotherapy, including intrapleural chemotherapy\n\nEndocrine therapy:\n\n* See Disease Characteristics\n\nRadiotherapy:\n\n* See Disease Characteristics\n* No prior radiotherapy to study lesion (unless evidence of disease progression) or to 30% or greater of marrow bearing bones\n* At least 1 week since prior radiotherapy and recovered\n* No concurrent radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n* At least 2 weeks since prior major surgery\n* No concurrent surgery\n\nOther:\n\n* At least 2 weeks since prior investigational drugs\n* No other concurrent cytotoxic anticancer therapy\n* No other investigational drugs during and for 30 days after study"
},
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}
}
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"then_criteria": null,
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},
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"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* No prior biological response modifiers",
"criterions": [
{
"exact_snippets": "No prior biological response modifiers",
"criterion": "prior biological response modifiers",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No prior biological response modifiers",
"criterion": "prior biological response modifiers",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
]
}