Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007943
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2001-01-06
Brief Title:
Gemcitabine in Treating Patients With Advanced Colorectal Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase II Study Of Twenty-Four Hour Infusion Gemcitabine For Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2021-09
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 gemcitabine in treating patients who have advanced colorectal cancer
PURPOSE Phase II trial to study the effectiveness of gemcitabine in treating patients who have advanced colorectal cancer
Detailed Description:
OBJECTIVES
Determine the response rate in patients with advanced colorectal cancer treated with gemcitabine
Determine the toxic effects of this drug in these patients
Determine the progression-free survival of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive gemcitabine IV continuously over 24 hours on days 1 8 and 15 Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months
PROJECTED ACCRUAL A total of 12-41 patients will be accrued for this study within 2 years
Determine the response rate in patients with advanced colorectal cancer treated with gemcitabine
Determine the toxic effects of this drug in these patients
Determine the progression-free survival of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive gemcitabine IV continuously over 24 hours on days 1 8 and 15 Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months
PROJECTED ACCRUAL A total of 12-41 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CCCWFU-59198 | None | None | None |
| NCI-914 | None | None | None |