A Randomized Phase II Study Of Triapine® Alone Versus Triapine and Gemcitabine As Second-Line Treatment Of Advanced Non-Small-Cell-Lung Cancer In Patients Who Had Prior Gemcitabine With Evaluation Of The Effect Of Triapine® On Gemcitabine Pharmacokinetics and Cellular Uptake In Peripheral Mononuclear Cells
- Determine the objective response rate in patients with stage III or IV recurrent
non-small cell lung cancer treated with 3-AP (Triapine®) and gemcitabine as second-line
- Determine the response duration, median time to progression, and overall survival of
patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the effect of 3-AP (Triapine®) on gemcitabine pharmacokinetics and cellular
uptake into peripheral mononuclear cells in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
Patients receive 3-AP (Triapine®) IV over 4 hours and gemcitabine IV over 30 minutes on days
1, 8, and 15*. Treatment repeats every 28 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
NOTE: *For course 1 only, gemcitabine is administered alone on day 1 and in combination with
3-AP (Triapine®) on days 8 and 15.
Patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 15-31 patients will be accrued for this study within 7.5-21
Masking: Open Label, Primary Purpose: Treatment
Objective tumor response as assessed by RECIST criteria
Brigette Ma, MD
Prince of Wales Hospital
United States: Federal Government