arsenic trioxide in treating patients with locally advanced or metastatic non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy, such as arsenic trioxide, use different ways to stop tumor cells from dividing so they stop growing or die. purpose: this phase ii trial is studying how well arsenic trioxide works in treating patients with locally advanced or metastatic non-small cell lung cancer.

objectives: primary * determine the safety and activity of arsenic trioxide in patients with locally advanced or metastatic non-small cell lung cancer. * determine the qualitative and quantitative toxic effects of this drug in these patients. secondary * determine the response, in terms of objective tumor response and response duration, in patients treated with this drug. * determine the patterns of failure and survival in patients treated with this drug. outline: this is a pilot study. patients receive arsenic trioxide iv over 1-2 hours on days 1-5 of week 1 and on days 1 and 5 of weeks 2-8 (course 1 only). beginning with course 2 and for all subsequent courses, patients receive arsenic trioxide on days 1 and 5 of weeks 1-8. treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. patients achieving complete response (cr) receive 1 additional course of therapy beyond cr. patients achieving cr due to local consolidative therapy (surgery or radiotherapy) receive 2 additional courses of therapy beyond cr. patients are followed for 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 14-30 patients will be accrued for this study within 9-18 months.

Eligibility criteria:
disease characteristics: * histologically confirmed non-small cell lung cancer (nsclc), meeting criteria for 1 of the following: * locally advanced disease not amenable to radiotherapy or surgery * metastatic disease * received at least 1 course of platinum-based (e.g., cisplatin or carboplatin) chemotherapy * no uncontrolled central nervous system (cns) metastases * ineligible for higher priority treatment protocols patient characteristics: age * 18 and over performance status * eastern cooperative oncology group (ecog) 0-1 or * zubrod scale 0-1 or * south west oncology group (swog) 0-1 life expectancy * at least 12 weeks hematopoietic * absolute neutrophil count greater than 1,500/mm\^3 * platelet count greater than 100,000/mm\^3 hepatic * bilirubin no greater than 1.5 times normal * serum glutamate oxaloacetate transaminase (sgot) and serum glutamate pyruvate transaminase (sgpt) no greater than 3 times normal renal * creatinine no greater than 2.0 mg/dl * calcium no greater than 12 mg/dl cardiovascular * no myocardial infarction within the past 6 months * no uncontrolled, clinically significant dysrhythmia * cardiac ejection fraction greater than 50% other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * electrolytes (including magnesium) normal * no other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * no prior or ongoing peripheral neuropathy grade 2 or greater * no other medical condition that would preclude study participation prior concurrent therapy: biologic therapy * no concurrent cytokine therapy chemotherapy * see disease characteristics * no more than 2 prior chemotherapy regimens for nsclc * no other concurrent chemotherapy endocrine therapy * not specified radiotherapy * more than 2 weeks since prior radiotherapy * no prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion * no concurrent radiotherapy * concurrent palliative or emergent radiotherapy allowed surgery * more than 2 weeks since prior surgery other * at least 4 weeks since prior antineoplastic agents for non-malignant conditions (e.g., methotrexate for rheumatoid arthritis) * no concurrent antineoplastic agents for non-malignant conditions

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