RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill more tumor cells by making them more sensitive to the drug. PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with recurrent, unresectable, or metastatic pancreatic cancer.
OBJECTIVES: Primary * 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. Secondary * 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 this regimen. * 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 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Objective response (complete and partial)
Time frame: Every 8 weeks for the duration of the trial, an expected average of 5 years
Prolonged stable disease rate
Time frame: Stable disease of 6 or more months
Median survival
Time frame: For duration of trial, an expected average of 5 years
Survival rate at 1 year
Time frame: 1 year
Response duration
Time frame: From date of response until progression
Progression-free survival
Time frame: From date of response until progression or death
Safety and tolerability
Time frame: Up to 1 year
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