Stage IIIA Gallbladder Cancer Clinical Trial
Official title:
A Phase II Study of Triapine in Combination With Gemcitabine in Adenocarcinoma of the Biliary Ducts and Gall Bladder
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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