Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075504
Status:
COMPLETED
Last Update Posted:
2015-09-28
First Post:
2004-01-09
Brief Title:
Triapine and Gemcitabine Hydrochloride in Gallbladder Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Triapine in Combination With Gemcitabine in Adenocarcinoma of the Biliary Ducts and Gall Bladder
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CM62204 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62204 |
| 6254 | OTHER | None | None |
| U01CA062505 | NIH | None | None |