Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003225
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
1999-11-01
Brief Title:
Amifostine Plus Irinotecan in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Phase III Trial to Evaluate Ethyol as a Protective Agent for Irinotecan CPT-11 Toxicities in Patients With Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
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 III trial to study the effectiveness of amifostine plus irinotecan in treating patients with metastatic colorectal cancer
PURPOSE Phase III trial to study the effectiveness of amifostine plus irinotecan in treating patients with metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Assess the toxicity profile of irinotecan and amifostine when administered together in patients with metastatic colorectal cancer II Assess the total dose of irinotecan received per 6 week course in these patients III Determine the incidence of irinotecan-induced leukopenia neutropenia and diarrhea in these patients V Determine the response rate for this patient population
OUTLINE This is an open label study Amifostine is administered by 10 minute IV infusions Irinotecan is administered by IV infusions 15 minutes after completion of amifostine Treatment is repeated every 2 weeks for 6 weeks This 6 week course is repeated in the absence of disease progression Treatment may be delayed up to 2 weeks after a course to allow for recovery from toxic effects Patients are followed at the end of study and at 30 days after study
PROJECTED ACCRUAL There will be 25-30 patients accrued into this study
OUTLINE This is an open label study Amifostine is administered by 10 minute IV infusions Irinotecan is administered by IV infusions 15 minutes after completion of amifostine Treatment is repeated every 2 weeks for 6 weeks This 6 week course is repeated in the absence of disease progression Treatment may be delayed up to 2 weeks after a course to allow for recovery from toxic effects Patients are followed at the end of study and at 30 days after study
PROJECTED ACCRUAL There will be 25-30 patients accrued into this study
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-G98-1390 | None | None | None |
| UCLA-HSPC-970304601B | None | None | None |
| ALZA-UCLA-HSPC-970304601B | None | None | None |