A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer
- Determine the objective response rate (partial and complete response) in patients with
unresectable or metastatic pancreatic cancer treated with 3-AP and gemcitabine.
- Determine the progression-free interval and survival of patients treated with this
- Determine the safety and feasibility of this regimen in these patients.
OUTLINE: This is a multicenter study.
- Stage I: Patients receive 3-AP IV over 4 hours and gemcitabine IV over 30 minutes on
days 1, 8, and 15. Treatment repeats every 4 weeks for up to 12 courses in the absence
of disease progression or unacceptable toxicity.
- Stage II: Patients receive a higher dose of 3-AP IV continuously over 24 hours on days
1, 8, and 15. Within 1 hour of completing 3-AP administration, patients receive
gemcitabine IV over 30 minutes on days 2, 9, and 16. Treatment repeats every 4 weeks
for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month, every 2 months for 6 months, and then every 3 months for
PROJECTED ACCRUAL: A total of 50-95 patients will be accrued for this study within 18-24
Masking: Open Label, Primary Purpose: Treatment
Objective response rate (partial and complete response) as assessed by RECIST criteria
Mario Sznol, MD
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|
|Sarah Cannon Cancer Center at Centennial Medical Center||Nashville, Tennessee 37203|
|Indiana Oncology Hematology Consultants||Indianapolis, Indiana 46202|