Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085371
Status:
COMPLETED
Last Update Posted:
2013-10-08
First Post:
2004-06-10
Brief Title:
Triapine as First-Line or Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of Triapine For Advanced Adenocarcinoma Of The Pancreas
Status:
COMPLETED
Status Verified Date:
2013-10
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 triapine works as first-line or second-line therapy in treating patients with locally advanced or metastatic adenocarcinoma cancer of the pancreas Drugs used in chemotherapy such as triapine work in different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I Determine the 3- and 6-month survival rate of patients with locally advanced or metastatic adenocarcinoma of the pancreas treated with 3-AP Triapine as first- or second-line therapy
SECONDARY OBJECTIVES
I Determine the toxicity and tolerability of this drug in these patients II Determine the time to treatment failure in patients treated with this drug III Determine overall survival and disease progression in patients treated with this drug
IV Determine tumor response in patients treated with this drug V Determine laboratory studies that will increase our understanding of Triapine and its effects on cellular processes
OUTLINE This is a multicenter study Patients are stratified according to prior chemotherapy yes vs no
Patients receive triapene IV over 2 hours on days 1-4 and 15-18 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3-6 months for 3 years
I Determine the 3- and 6-month survival rate of patients with locally advanced or metastatic adenocarcinoma of the pancreas treated with 3-AP Triapine as first- or second-line therapy
SECONDARY OBJECTIVES
I Determine the toxicity and tolerability of this drug in these patients II Determine the time to treatment failure in patients treated with this drug III Determine overall survival and disease progression in patients treated with this drug
IV Determine tumor response in patients treated with this drug V Determine laboratory studies that will increase our understanding of Triapine and its effects on cellular processes
OUTLINE This is a multicenter study Patients are stratified according to prior chemotherapy yes vs no
Patients receive triapene IV over 2 hours on days 1-4 and 15-18 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3-6 months for 3 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 |
|---|---|---|---|
| N01CM62205 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62205 |
| NCI-2012-01452 | REGISTRY | None | None |
| MAYO-MC0345 | None | None | None |
| CDR0000368762 | None | None | None |
| NCI-6293 | None | None | None |
| MC0345 | OTHER | None | None |
| 6293 | OTHER | None | None |