Finding studies
Finding studies
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Lead
Cancer Therapeutics Research Group
With
OBJECTIVES: Primary * 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 therapy. Secondary * 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 participating center. 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 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
