Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003950
Status:
COMPLETED
Last Update Posted:
2014-03-07
First Post:
1999-11-01
Brief Title:
Irinotecan and Cyclosporine in Treating Patients With Metastatic Advanced or Locally Recurrent Colorectal Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase II Trial of Irinotecan CPT-11 and Cyclosporine in Patients With 5-FU Refractory Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2014-03
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 Cyclosporine may relieve the diarrhea caused by irinotecan
PURPOSE Phase II trial to study the effectiveness of irinotecan and cyclosporine in treating patients who have metastatic advanced or locally recurrent colorectal cancer that has not responded to fluorouracil
PURPOSE Phase II trial to study the effectiveness of irinotecan and cyclosporine in treating patients who have metastatic advanced or locally recurrent colorectal cancer that has not responded to fluorouracil
Detailed Description:
OBJECTIVES I Determine the response rate of patients with metastatic advanced or locally recurrent fluorouracil refractory adenocarcinoma of the colon or rectum treated with irinotecan and cyclosporine II Determine antitumor activity safety tolerance and toxicity of this combination treatment in these patients
OUTLINE This is a multicenter study Patients receive cyclosporine IV over 6 hours and irinotecan IV over 90 minutes weekly for 4 weeks Courses repeat every 6 weeks Patients receive at least 2 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 15-45 patients will be accrued for this study over 14 months
OUTLINE This is a multicenter study Patients receive cyclosporine IV over 6 hours and irinotecan IV over 90 minutes weekly for 4 weeks Courses repeat every 6 weeks Patients receive at least 2 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 15-45 patients will be accrued for this study over 14 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-T98-0049 | None | None | None |
| UCCRC-T98-0049 | None | None | None |