NCT00075504

Triapine and Gemcitabine Hydrochloride in Gallbladder Cancer

A Phase II Study of Triapine in Combination With Gemcitabine in Adenocarcinoma of the Biliary Ducts and Gall Bladder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with unresectable or metastatic bile duct or gallbladder cancer. 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 cancer cells by making them more sensitive to the drug.

Detailed description

OBJECTIVES: I. To determine the objective response rates for the combination of triapine and gemcitabine in patients with primary tumors of the biliary ducts and gall bladder. II. To assess the toxicities and recovery from toxicities for patients with biliary duct and gall bladder tumors treated with the combination of triapine and gemcitabine. III. To determine the survival and progression free survival of patients with biliary and gall bladder tumors treated with the combination of triapine and gemcitabine. OUTLINE: This is a non-randomized, multicenter study. Patients are stratified according to bilirubin levels (normal vs abnormal). Patients receive 3-AP (Triapine) IV over 4 hours followed by 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 response (CR) receive 1 additional course beyond CR. Patients are followed every 3 months for up to 2 years.

Conditions

• Stage II Gallbladder Cancer
• Stage IIIA Gallbladder Cancer
• Stage IIIB Gallbladder Cancer
• Stage IVA Gallbladder Cancer
• Stage IVB Gallbladder Cancer

Interventions

Type	Name	Description
DRUG	triapine	Given IV
DRUG	gemcitabine	Given IV

Timeline

• Start date: 2003-11-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2004-01-12
• Last updated: 2015-09-28
• Results posted: 2015-09-28

Locations

1 site across 1 country: United States