soblidotin in treating patients with progressive locally advanced or metastatic non-small cell lung cancer

Conditions: Lung Cancer

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

objectives: * determine the objective tumor response rate and duration of response in patients with progressive locally advanced or metastatic non-small cell lung cancer treated with soblidotin as second-line therapy after receiving prior platinum-based chemotherapy. * determine the time to tumor progression in patients treated with this drug. * determine the median survival time and 12-month survival rate of patients treated with this drug. * determine the quantitative and qualitative toxic effects of this drug in these patients. * determine the pharmacokinetics of this drug in these patients. outline: this is an open-label, multicenter study. patients receive soblidotin iv over 1 hour on days 1 and 8. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. plasma sampling for pharmacokinetics is done on day 1 of course 1. patients are followed for survival every 3 months after discontinuing study treatment. projected accrual: a total of 27 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: * histologically confirmed non-small cell lung cancer * locally advanced or metastatic disease * demonstrates tumor progression * must have received 1 prior chemotherapy regimen * prior chemotherapy must have included a platinum agent * measurable disease * at least 1 measurable lesion outside the field of any prior radiotherapy * no symptomatic brain metastases 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 greater than 100,000/mm\^3 hepatic * bilirubin no greater than 1.5 times upper limit of normal (uln) * ast/alt no greater than 2.5 times uln (5 times uln if liver metastases are present) renal * creatinine no greater than 1.5 times uln cardiac * ejection fraction at least 40% by muga other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no psychiatric disorder that would preclude giving informed consent or following study instruction * no grade 2 or greater neurotoxicity * no other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless in complete remission and off therapy for that disease for at least 5 years prior to study entry * no other concurrent severe or uncontrolled underlying medical disease that would compromise patient safety and study outcome * no concurrent serious infection prior concurrent therapy: biologic therapy * no concurrent anticancer biologic therapy chemotherapy * see disease characteristics * recovered from prior chemotherapy * no other concurrent anticancer chemotherapy endocrine therapy * not specified radiotherapy * see disease characteristics * recovered from prior radiotherapy * no concurrent anticancer radiotherapy * concurrent localized radiotherapy to a non-indicator lesion for pain relief is allowed provided other methods of pain control are ineffective surgery * at least 4 weeks since prior major surgery and recovered other * at least 4 weeks since prior myelosuppressive therapy * more than 28 days since prior investigational drugs * no other concurrent investigational drugs * no other concurrent anticancer cytotoxic therapy

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