NCT00064051

3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer

A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Vion Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride
DRUG	triapine

Timeline

• Start date: 2003-01-01
• Primary completion: 2006-08-01
• Completion: 2008-08-01
• First posted: 2003-07-09
• Last updated: 2013-08-02

Locations

7 sites across 3 countries: United States, Belgium, United Kingdom