Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Phase II Protocol Of Arsenic Trioxide (Trisenox) In Subjects With Advanced Non-Small Cell Carcinoma Of The Lung

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: arsenic trioxide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: arsenic trioxide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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