Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IIIB* or IV disease NOTE: *Due to malignant pleural effusion or supraclavicular lymph node involvement only Previously treated with maximally feasible surgical resection and/or radiotherapy for initial disease Failed 1 prior platinum-containing chemotherapy regimen for advanced or metastatic disease due to disease progression or treatment toxicity At least 1 site of unidimensionally measurable disease by physical exam or radiography No known CNS metastases or leptomeningeal metastases requiring corticosteroids PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy More than 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Hemoglobin ≥ 8 g/dL Platelet count ≥ 75,000/mm^3 Hepatic AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with hepatic metastases) Alkaline phosphatase ≤ 5 times ULN Bilirubin ≤ 1.8 mg/dL Renal Creatinine ≤ 2.0 mg/dL Cardiovascular No New York Heart Association class III or IV congestive heart failure No personal or family history of congenital long QT syndrome No QTc interval > 450 msec (males) or > 470 msec (females) by ECG Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No preexisting neuropathy ≥ grade 2 No other malignancy within the past 5 years except for the following: Cured basal cell skin cancer Carcinoma in situ of the cervix or urinary bladder Stage T1 or T2 prostate cancer with prostate-specific antigen < 2 ng/mL No hypersensitivity reaction ≥ grade 3 to prior Cremophor-containing therapy No infection requiring parenteral or oral anti-infective therapy No weight loss of ≥ 10% within the past 3 months No altered mental status or psychiatric illness that would preclude giving informed consent No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent granulocyte-macrophage colony-stimulating factor (sargramostim [GM-CSF]) No concurrent routine prophylactic granulocyte colony-stimulating factor (filgrastim [G-CSF]) Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy See Disease Characteristics Radiotherapy See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered Surgery See Disease Characteristics At least 3 weeks since prior surgery and recovered Other Prior adjuvant or neoadjuvant therapy allowed Prior radiosensitizers allowed At least 2 weeks since prior gefitinib More than 3 weeks since prior investigational agents (therapeutic or diagnostic) No other concurrent investigational agents No other concurrent anticancer treatment
Sites / Locations
- Memorial Sloan-Kettering Cancer Center