A Pilot Phase II Protocol Of Arsenic Trioxide (Trisenox) In Subjects With Advanced Non-Small Cell Carcinoma Of The Lung
- 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
- 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
Masking: Open Label, Primary Purpose: Treatment
Dennie V. Jones, MD
University of Texas
United States: Federal Government
|University of Texas Medical Branch||Galveston, Texas 77555-1329|