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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.
- 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.
- 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.
Masking: Open Label, Primary Purpose: Treatment
University of Texas Medical Branch
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-23T21:52:10-0400
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