3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with 3-AP works in treating patients with unresectable or metastatic pancreatic cancer.
Drug: gemcitabine hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer|
- Objective response rate (partial and complete response) as assessed by RECIST criteria [ Designated as safety issue: No ]
- Progression-free and overall survival [ Designated as safety issue: No ]
- Safety and feasibility [ Designated as safety issue: Yes ]
|Study Start Date:||January 2003|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
- 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 regimen.
- 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 18 months.
PROJECTED ACCRUAL: A total of 50-95 patients will be accrued for this study within 18-24 months.
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Indiana|
|Indiana Oncology Hematology Consultants|
|Indianapolis, Indiana, United States, 46202|
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|United States, Tennessee|
|Sarah Cannon Cancer Center at Centennial Medical Center|
|Nashville, Tennessee, United States, 37203|
|Universitair Ziekenhuis Gent|
|Ghent, Belgium, B-9000|
|Christie Hospital N.H.S. Trust|
|Manchester, England, United Kingdom, M20 4BX|
|Royal Marsden NHS Foundation Trust - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||Mario Sznol, MD||Vion Pharmaceuticals|