Stage IV Pancreatic Cancer Clinical Trial
Official title:
A Phase II Study Of Triapine For Advanced Adenocarcinoma Of The Pancreas
This phase II trial is studying how well triapine works as first-line or second-line therapy in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the pancreas. Drugs used in chemotherapy, such as triapine, work in different ways to stop tumor cells from dividing so they stop growing or die.
PRIMARY OBJECTIVES:
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
second-line therapy.
SECONDARY OBJECTIVES:
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
processes.
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
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