Triapine and Gemcitabine Hydrochloride in Treating Patients With Bile Duct or Gallbladder Cancer That is Metastatic or Cannot Be Removed By Surgery
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.
Adenocarcinoma of the Extrahepatic Bile Duct
Metastatic Extrahepatic Bile Duct Cancer
Stage II Gallbladder Cancer
Stage IIIA Gallbladder Cancer
Stage IIIB Gallbladder Cancer
Stage IVA Gallbladder Cancer
Stage IVB Gallbladder Cancer
Unresectable Extrahepatic Bile Duct Cancer
Drug: gemcitabine hydrochloride
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Triapine in Combination With Gemcitabine in Adenocarcinoma of the Biliary Ducts and Gall Bladder|
- Response rate according to RECIST criteria [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2003|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Experimental: Treatment (triapine, gemcitabine hydrochloride)
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 CR receive 1 additional course beyond CR.
Other Names:Drug: gemcitabine hydrochloride
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 bilary 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075504
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467-2490|
|Principal Investigator:||Allyson Ocean||Montefiore Medical Center|