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Eligibility: 32ca04130c17eb6eddba7548171a4a00 [RDF]

Label 32ca04130c17eb6eddba7548171a4a00
Slug 32ca04130c17eb6eddba7548171a4a00
Criteria DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer - Chemotherapy-naive - Stage IIIB disease not amenable to surgery with pleural effusion, pericardial effusion, or not a candidate for chemoradiotherapy - Stage IV disease - Must have pathology block or unstained slides from initial or subsequent diagnosis - Diagnosis made via a core biopsy (not a fine-needle aspirate) required - Measurable disease as defined by RECIST guidelines - For patient who received prior radiotherapy, evaluable disease must be outside of the radiation field, or have new lesions that developed within the radiation field - Brain metastasis allowed provided it has been treated and determined to be controlled by the treating physician - No IgE cetuximab antibody PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - ANC ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 8.0 g/dL - Creatinine < 2.0 times upper limit of normal (ULN) - AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastasis) - Bilirubin ≤ 1.5 times ULN - Prior malignancy allowed provided the treating physician determines that the patient's life expectancy is best defined by diagnosis of non-small cell lung cancer (NSCLC) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No peripheral neuropathy ≥ grade 2 by NCI CTCAE v. 3.0 - No prior severe allergic reaction to any of the following: - Carboplatin - Taxane therapy - Monoclonal antibody - Hypersensitivity (NCI CTCAE grade3-4) to a drug formulated in Cremophor® EL (polyoxyethylated castor oil) - No active or uncontrolled infection - No significant history of uncontrolled cardiac disease including, but not limited to, any of the following: - Uncontrolled hypertension - Unstable angina - Myocardial infarction within the past 6 months - Uncontrolled congestive heart failure - Cardiomyopathy with decreased ejection fraction - No underlying interstitial lung disease PRIOR CONCURRENT THERAPY: - See Disease Characteristics - At least 1 week since prior and no concurrent therapeutic radiotherapy - Palliative radiotherapy for painful bone lesions allowed - At least 6 months since prior adjuvant chemotherapy - No investigational agent(s) within the past 30 days - Not requiring concurrent treatment with any of the following: - Ketoconazole - Itraconazole - Ritonavir - Amprenavir - Indinavir - Nelfinavir - Delavirdine - Voriconazole - No other concurrent chemotherapy or cetuximab
Maximum age N/A
Healthy volunteers No
Study pop
Minimum age 18 Years
Gender Both
Sampling method
Provenances http://clinicaltrials.gov/show/NCT00998101?displayxml=true
Similars None
Interlinks None