Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00524706
Status:
UNKNOWN
Last Update Posted:
2008-11-13
First Post:
2007-09-04
Brief Title:
Phase III Study of SOL for Untreated Metastatic Colorectal Cancer
Sponsor:
Shizuoka Cancer Center
Organization:
Shizuoka Cancer Center
Study Overview
Official Title:
Phase III Study of S-1 Oral Leucovorin and Oxaliplatin Combination Therapy SOL in Patients With Untreated Metastatic Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2008-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Introduction
S-1 is promising drug which could replace 5-fluorouracil plus l-leucovorin 5-FUl-LV in treatment of advanced colorectal cancer
Phase III study of S-1 plus Oxaliplatin SOX demonstrated its promising activity with acceptable toxicity as first-line chemotherapy in patients with untreated metastatic colorectal cancer and S-1 showed equivalent possibility to 5-FUl-LV On the other hand phase III study of S-1 plus oral Leucovorin S-1LV demonstrated that this regimen had enhanced efficacy in comparison with S-1 alone From these results it was expected that S-1LV plus Oxaliplatin SOL would be more effective than SOX
Therefore phase III study of SOL combination therapy was planned
Purpose A dose-finding study of S-1LV plus Oxaliplatin SOL was planned to determine the recommended dose RD and to assess the response rate RR in patients with untreated metastatic colorectal cancer The primary endpoints of the phase I portion are determination of the RD of SOL and safety
The phase II portion of this study was aimed to assess the RR of SOL
S-1 is promising drug which could replace 5-fluorouracil plus l-leucovorin 5-FUl-LV in treatment of advanced colorectal cancer
Phase III study of S-1 plus Oxaliplatin SOX demonstrated its promising activity with acceptable toxicity as first-line chemotherapy in patients with untreated metastatic colorectal cancer and S-1 showed equivalent possibility to 5-FUl-LV On the other hand phase III study of S-1 plus oral Leucovorin S-1LV demonstrated that this regimen had enhanced efficacy in comparison with S-1 alone From these results it was expected that S-1LV plus Oxaliplatin SOL would be more effective than SOX
Therefore phase III study of SOL combination therapy was planned
Purpose A dose-finding study of S-1LV plus Oxaliplatin SOL was planned to determine the recommended dose RD and to assess the response rate RR in patients with untreated metastatic colorectal cancer The primary endpoints of the phase I portion are determination of the RD of SOL and safety
The phase II portion of this study was aimed to assess the RR of SOL
Detailed Description:
None
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