bay 59-8862 in treating patients with non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of bay 59-8862 in treating patients who have non-small cell lung cancer.

objectives: * determine the overall response rate, including partial and complete response, in patients with taxane-resistant non-small cell lung cancer treated with bay 59-8862. * determine the overall survival of patients treated with this drug. * determine duration of response and time to progression in patients treated with this drug. * determine the quantitative and qualitative toxic effects of this drug in these patients. outline: this is a multicenter study. patients receive bay 59-8862 iv over 1 hour on day 1. courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. patients with responding disease receive 2-4 additional courses beyond maximal response. patients are followed every 3 months for 2 years and then every 6 months thereafter. projected accrual: a total of 14-84 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed non-small cell lung cancer * measurable disease * a cns lesion cannot be the sole target lesion * must be taxane-resistant as defined by the following criteria: * at least 1 prior course (3 weeks of continuous therapy) of a taxane * progressive disease developed either during or within 6 months after therapy * no metastatic brain or meningeal tumors unless the following criteria apply: * more than 6 months since definitive therapy * negative imaging study within the past 4 weeks * clinically stable with respect to the tumor * no concurrent acute steroid therapy or taper * chronic steroids allowed provided dose is stable for 1 month before and after screening radiography patient characteristics: age * 18 and over performance status * ecog 0-2 life expectancy * at least 12 weeks hematopoietic * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 9.0 g/dl hepatic * bilirubin no greater than 1.5 times upper limit of normal (uln) * alt and ast no greater than 2.5 times uln (5 times uln if liver involvement) * no chronic hepatitis b or c renal * creatinine no greater than 1.5 times uln cardiovascular * no congestive heart failure * no serious cardiac arrhythmias * no active coronary disease or ischemia other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective barrier contraception * hiv negative * no active clinically serious infection * no history of seizure disorder * history of seizures related to brain metastasis allowed if seizure free for the past 2 months * no prior hypersensitivity to taxane compounds that was unmanageable with premedication * no pre-existing peripheral neuropathy greater than grade 1 * no other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (ta, tis, and t1) * no substance abuse * no medical, psychological, or social condition that would preclude study participation or evaluation * no condition that is unstable or would jeopardize patient safety and study compliance prior concurrent therapy: biologic therapy * more than 3 weeks since prior anticancer immunotherapy * more than 3 weeks since prior biologic response modifiers (e.g., filgrastim \[g-csf\]) * more than 4 months since prior bone marrow transplantation or stem cell rescue * no concurrent anticancer immunotherapy * concurrent epoetin alfa allowed if dose is stable for the past 2 months chemotherapy * see disease characteristics * more than 3 weeks since prior anticancer chemotherapy (6 weeks for mitomycin or nitrosoureas) * no more than 2 prior anticancer chemotherapy regimens (adjuvant therapy is not included unless cancer recurred during or within 6 months after completion of adjuvant therapy) * no prior oxaliplatin * no other concurrent chemotherapy endocrine therapy * see disease characteristics radiotherapy * more than 3 weeks since prior radiotherapy * no concurrent non-palliative radiotherapy * palliative radiotherapy allowed provided that all of the following criteria are met: * no progressive disease * no more than 10% of the bone marrow is irradiated * radiation field does not encompass a target lesion surgery * more than 4 weeks since prior surgery * no prior organ allograft other * more than 4 weeks since prior investigational drug therapy * no concurrent non-conventional therapies (e.g., herbs or acupuncture) or vitamin/mineral supplements that would interfere with study endpoints * no other concurrent investigational drug therapy * no other concurrent anticancer therapy

Keywords: recurrent non-small cell lung cancer