Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053222
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
2003-01-27
Brief Title:
Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase II Study Of Arsenic Trioxide In Patients With Adenocarcinoma Of The Pancreas Refractory To Gemcitabine
Status:
COMPLETED
Status Verified Date:
2013-09
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have locally advanced or metastatic pancreatic cancer that has not responded to gemcitabine
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have locally advanced or metastatic pancreatic cancer that has not responded to gemcitabine
Detailed Description:
OBJECTIVES
Determine the objective response rate to arsenic trioxide in patients with pancreatic cancer who have progressed after first-line treatment with a gemcitabine-containing regimen when treated with arsenic trioxide
Determine the toxicity of this drug in these patients
Determine the duration of response median and overall survival and time to progression in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive arsenic trioxide IV over 1 hour on days 1-5 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 9-12 months
Determine the objective response rate to arsenic trioxide in patients with pancreatic cancer who have progressed after first-line treatment with a gemcitabine-containing regimen when treated with arsenic trioxide
Determine the toxicity of this drug in these patients
Determine the duration of response median and overall survival and time to progression in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive arsenic trioxide IV over 1 hour on days 1-5 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 9-12 months
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 |
|---|---|---|---|
| NCI-5839 | None | None | None |
| UCCRC-11839A | None | None | None |