A Phase II Study of Triapine in Combination With Gemcitabine in Recurrent/Unresectable/Metastatic Pancreatic Carcinoma
- Determine the antitumor activity of 3-AP (Triapine®) and gemcitabine, in terms of
complete and partial response and 6-month progression-free disease, in patients with
recurrent, unresectable, or metastatic pancreatic cancer.
- Determine the objective response rates, median survival, 1-year survival rate, duration
of response or stable disease, and progression-free survival of patients treated with
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive 3-AP (Triapine®) IV over 2 hours and gemcitabine IV over 30 minutes on days
1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity. Patients achieving a complete or partial response
receive an additional 2 courses of therapy beyond response.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 28-50 patients will be accrued for this study within 7-13
Masking: Open Label, Primary Purpose: Treatment
Objective response (complete and partial)
Malcolm J. Moore, MD
Princess Margaret Hospital, Canada
United States: Federal Government