Spots Global Cancer Trial Database for 3-AP and Gemcitabine in Treating Patients With Recurrent, Unresectable, or Metastatic Pancreatic Cancer

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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