Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129870
Status:
TERMINATED
Last Update Posted:
2009-02-13
First Post:
2005-08-10
Brief Title:
CONCEPT Comparison of Oxaliplatin vs Conventional Methods With CalciumMagnesium in First-Line Metastatic Colorectal Cancer
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
CONCEPT - Phase IV Randomized Prospective Multicenter Comparison of Intermittent Schedule of Oxaliplatin Combined With FOLFOXBevacizumab vs Conventional Mode of Administration of FOLFOXBevacizumab Neuroprophylaxis With CalciumMagnesium for Optimization of First-Line Therapy of Metastatic Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unplanned interim analysis by DSMB indicated possible reduced response rate with the addition of CaMg in pooled population Further analysis pending
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary rationale for this study is to develop an optimized schedule of administration of FOLFOX bevacizumab that maximizes the efficacy and safety of this regimen when administered to patients with advanced colorectal cancer The hypothesis is that the use of an intermittent oxaliplatin IO schedule of FOLFOXbevacizumab will allow these patients to continue on treatment for a longer period of time by reducing the proportion of patients who discontinue therapy early because of treatment-related toxicities and thus increasing the possibility of a longer time to progression
The primary objective is
To test the hypothesis that an intermittent oxaliplatin IO schedule of FOLFOXbevacizumab will allow patients to remain on therapy for a longer period of time compared to a conventional treat-to-failure schedule by reducing the proportion of patients who discontinue therapy for treatment-related toxicities
The secondary objectives are
To evaluate the impact of calciummagnesium infusions on the incidence and severity of neurotoxicity in subjects receiving either the IO or conventional FOLFOXbevacizumab treatment schedules as first-line treatment for metastatic colorectal cancer
To evaluate the safety and efficacy of the IO versus the conventional schedule calcium and magnesium infusions as part of oxaliplatin-based first-line therapy for metastatic colorectal cancer
The primary objective is
To test the hypothesis that an intermittent oxaliplatin IO schedule of FOLFOXbevacizumab will allow patients to remain on therapy for a longer period of time compared to a conventional treat-to-failure schedule by reducing the proportion of patients who discontinue therapy for treatment-related toxicities
The secondary objectives are
To evaluate the impact of calciummagnesium infusions on the incidence and severity of neurotoxicity in subjects receiving either the IO or conventional FOLFOXbevacizumab treatment schedules as first-line treatment for metastatic colorectal cancer
To evaluate the safety and efficacy of the IO versus the conventional schedule calcium and magnesium infusions as part of oxaliplatin-based first-line therapy for metastatic colorectal cancer
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