vnp40101m in treating patients with relapsed or refractory locally advanced or metastatic small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy, such as vnp40101m, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well vnp40101m works in treating patients with recurrent or refractory locally advanced or metastatic small cell lung cancer.

objectives: * determine the overall response rate (partial and complete) in patients with relapsed or refractory locally advanced or metastatic small cell lung cancer treated with vnp40101m. * determine the toxic effects of this drug in these patients. outline: this is a multicenter study. patients are stratified according to disease state (sensitive relapse \[progressive disease \> 3 months after responding to first-line chemotherapy\] vs resistant disease \[progressive disease during or ≤ 3 months after first-line chemotherapy\]). patients receive vnp40101m iv over 15-30 minutes once weekly for 3 weeks. treatment repeats every 6 weeks for up to 6 courses. patients achieving a complete response (cr) receive 2 additional courses of therapy after cr. after completion of study treatment, patients are followed periodically for up to 18 months. projected accrual: a total of 87 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * cytologically confirmed small cell lung cancer * locally advanced or metastatic disease * recurrent or progressive disease after first-line standard cytotoxic therapy * measurable or evaluable disease * brain metastasis allowed patient characteristics: * ecog performance status 0-2 * life expectancy ≥ 2 months * granulocyte count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * creatinine ≤ 2.0 mg/dl * bilirubin ≤ 2.5 mg/dl * ast and alt ≤ 3 times upper limit of normal (uln) (5 times uln if liver metastases present) * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no active uncontrolled bleeding * no active infection * must not require supplemental oxygen at rest * no active heart disease * no myocardial infarction within the past 3 months * no uncontrolled congestive heart failure * no uncontrolled arrhythmias * no uncontrolled coronary artery disease prior concurrent therapy: * see disease characteristics * more than 3 weeks since prior radiotherapy, biologic therapy or chemotherapy (6 weeks for nitrosoureas or mitomycin c) * prior radiotherapy within the past 3 weeks allowed if exposure involves no more than 30% of bones with significant bone marrow-producing capabilities (e.g., vertebral bodies and long bones) * at least 2 weeks since prior surgery or hormonal therapy * must not require any immediate palliative treatment including surgery * must have recovered from prior anticancer therapy * persistent, stable chronic toxic effects ≤ grade 1 are allowed * no more than 1 prior systemic chemotherapy regimen for locally advanced or metastatic disease * no other concurrent anticancer therapy * no other concurrent investigational agent * no concurrent disulfiram

Keywords: recurrent small cell lung cancer extensive stage small cell lung cancer limited stage small cell lung cancer