ABI-007 in Treating Patients With Chemotherapy-Naïve Stage IV Non-Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IV non-small cell lung cancer Evidence of inoperable local recurrence or metastasis Bone metastases or other nonmeasurable disease may not be only evidence of metastasis Measurable disease documented radiographically No evidence of active brain metastases or leptomeningeal involvement PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 OR Karnofsky 80-100% Life expectancy More than 12 weeks Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL Hepatic AST and ALT ≤ 2.5 times upper limit of normal (ULN) Bilirubin normal Alkaline phosphatase ≤ 2.5 times ULN (unless due to bone metastases and there is no radiologic evidence of hepatic metastases) Renal Creatinine ≤ 1.5 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception for 1 month before and during study participation No prior allergy or hypersensitivity to study drug No other concurrent active malignancy No pre-existing peripheral neuropathy grade 1 or greater No other concurrent clinically significant illness No concurrent serious medical risk factor involving any of the major organ systems that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for metastatic disease More than 4 weeks since prior cytotoxic chemotherapy No concurrent doxorubicin No other concurrent taxanes No concurrent anthracyclines Endocrine therapy Not specified Radiotherapy At least 3 weeks since prior radiotherapy to a major bone marrow-containing area More than 4 weeks since prior radiotherapy except to a non-target lesion Prior radiotherapy to a target lesion allowed provided there has been clear progression of the lesion since completion of radiotherapy Surgery Not specified Other Prior epidermal growth factor-targeted therapy allowed More than 4 weeks since prior investigational drugs No concurrent enrollment in another clinical trial in which investigational drugs are administered or investigational procedures are performed No concurrent treatment with any of the following: Ritonavir Saquinavir Indinavir Nelfinavir No concurrent anticonvulsants No other concurrent anticancer drugs No other concurrent investigational drugs
Sites / Locations
- Memorial Sloan-Kettering Cancer Center