Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094965
Status:
COMPLETED
Last Update Posted:
2009-03-30
First Post:
2004-10-28
Brief Title:
Oxaliplatin With FOLFOX4 in Patients With Normal and Abnormal Renal Function
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Phase II Trial of Oxaliplatin in Combination With BolusInfusional 5FULV FOLFOX4 in Patients With Advanced Gastrointestinal GI Cancers With Varying Degrees of Renal Impairment
Status:
COMPLETED
Status Verified Date:
2009-03
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:
FOLFOX4
Brief Summary:
This trial is a phase II study in patients with advanced gastrointestinal GI malignancies who will be assigned to one of 4 cohorts normal mild moderate and several renal dysfunction based on their baseline measured creatinine clearance then treated with FOLFOX4
Standard bone marrow and liver function inclusion and exclusion criteria must be met prior to study treatment FOLFOX4 in the study is given every 2 weeks 1 cycle 2 weeks for up to 12 cycles unless there are treatment delays to allow for recovery from toxic effects Dose modifications are included for protocol specified toxicities After 12 treatment cycles on study patients who are having a beneficial disease response may continue to have oxaliplatin supplied off study to continue the treatment regimen until disease progression prohibitive toxicity or death
Oxaliplatin pharmacokinetic studies plasma and urine are planned during cycles 1 and 2 on each patient Creatinine clearance will be assessed every 2 cycles and disease status will be assessed every 3 cycles of treatment during the study
Standard bone marrow and liver function inclusion and exclusion criteria must be met prior to study treatment FOLFOX4 in the study is given every 2 weeks 1 cycle 2 weeks for up to 12 cycles unless there are treatment delays to allow for recovery from toxic effects Dose modifications are included for protocol specified toxicities After 12 treatment cycles on study patients who are having a beneficial disease response may continue to have oxaliplatin supplied off study to continue the treatment regimen until disease progression prohibitive toxicity or death
Oxaliplatin pharmacokinetic studies plasma and urine are planned during cycles 1 and 2 on each patient Creatinine clearance will be assessed every 2 cycles and disease status will be assessed every 3 cycles of treatment during the study
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