A Phase II Study Of Triapine For Advanced Adenocarcinoma Of The Pancreas
I. Determine the 3- and 6-month survival rate of patients with locally advanced or
metastatic adenocarcinoma of the pancreas treated with 3-AP (Triapine^®) as first- or
I. Determine the toxicity and tolerability of this drug in these patients. II. Determine the
time to treatment failure in patients treated with this drug. III. Determine overall
survival and disease progression in patients treated with this drug.
IV. Determine tumor response in patients treated with this drug. V. Determine laboratory
studies that will increase our understanding of Triapine and its effects on cellular
OUTLINE: This is a multicenter study. Patients are stratified according to prior
chemotherapy (yes vs no).
Patients receive triapene IV over 2 hours on days 1-4 and 15-18. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3-6 months for 3 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival in patients receiving triapine as first-line therapy
The point estimate of the success rates will be calculated as the number of successes divided by the number of evaluable patients, with confidence intervals calculated by the method of Duffy and Santner.
United States: Food and Drug Administration
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