3-AP and Gemcitabine in Treating Patients With Recurrent, Unresectable, or Metastatic Pancreatic Cancer
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.
Drug: gemcitabine hydrochloride
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Triapine in Combination With Gemcitabine in Recurrent/Unresectable/Metastatic Pancreatic Carcinoma|
- Objective response (complete and partial) [ Time Frame: Every 8 weeks for the duration of the trial, an expected average of 5 years ] [ Designated as safety issue: No ]
- Prolonged stable disease rate [ Time Frame: Stable disease of 6 or more months ] [ Designated as safety issue: No ]
- Median survival [ Time Frame: For duration of trial, an expected average of 5 years ] [ Designated as safety issue: No ]
- Survival rate at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Response duration [ Time Frame: From date of response until progression ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: From date of response until progression or death ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2004|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
|Experimental: Triapine in combination with Gemcitabine||Drug: gemcitabine hydrochloride Drug: triapine|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00078975
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|London Regional Cancer Program at London Health Sciences Centre|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Hospital Regional Cancer Centre - General Campus|
|Ottawa, Ontario, Canada, K1H 1C4|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Malcolm J. Moore, MD||Princess Margaret Hospital, Canada|