Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209625
Status:
COMPLETED
Last Update Posted:
2005-09-21
First Post:
2005-09-13
Brief Title:
Phase I II Study of Irinotecan CPT-11 Combined With l-Leucovorin l-LV and 5-FU in Patients With Advanced Colorectal Cancer
Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Organization:
Hokkaido Gastrointestinal Cancer Study Group
Study Overview
Official Title:
Phase I II Study of Irinotecan CPT-11 Combined With l-Leucovorin l-LV and 5-FU in Patients With Advanced Colorectal CancerHokkaido Gastrointestinal Cancer Study GroupHGCSG0001
Status:
COMPLETED
Status Verified Date:
2000-04
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:
We performed a phase III study of CPT-115FUl-LV in advanced colorectal cancer to determine the optimal dose of CPT-11 and to estimate the safety and efficacy of this regimen
Detailed Description:
A multicenter Open-label single-arm phase III clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan leucovorin plus fluorouracil The usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free survival rate DFR median survival time MST incidence and severity of adverse event
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