epothilone d in treating patients with stage iiib or stage iv non-small cell lung cancer that has not responded to platinum-based chemotherapy

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy, such as epothilone d, work in different ways to stop tumor cells from dividing so they stop growing or die. purpose: this phase ii trial is studying how well epothilone d works in treating patients with stage iiib or stage iv non-small cell lung cancer that has not responded to platinum-based chemotherapy.

objectives: primary * determine the antitumor activity of epothilone d, in terms of confirmed objective response rate, in patients with stage iiib or iv non-small cell lung cancer who failed prior initial platinum-containing chemotherapy. secondary * determine the safety of this drug in these patients. * determine the response duration in patients who achieve complete response or partial response, time to tumor progression, and survival in patients treated with this drug. * compare the power associated with the estimated treatment effect of this drug in these patients vs standard treatment. * correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients. outline: this is a multicenter, open-label study. patients receive epothilone d iv over 90 minutes on days 1, 8, and 15. courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months. projected accrual: a total of 33-85 patients will be accrued for this study.

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

Keywords: recurrent non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer