Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268411
Status:
UNKNOWN
Last Update Posted:
2008-05-27
First Post:
2005-12-20
Brief Title:
Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas Gemox Et Gemox Simplifie GEMOX
Status:
UNKNOWN
Status Verified Date:
2007-05
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:
RATIONALE Drugs used in chemotherapy such as gemcitabine and oxaliplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells It is not yet known whether giving both of these drugs on the same day is more effective than giving them on different days
PURPOSE This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer
PURPOSE This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with two different schedules of gemcitabine hydrochloride and oxaliplatin
Secondary
Compare the clinical benefits and tolerability of these regimens in these patients
Compare the progression-free and overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to the participating center and ECOG performance status 0 or 1 vs 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2
Arm II Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on day 1
In both arms treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study
Primary
Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with two different schedules of gemcitabine hydrochloride and oxaliplatin
Secondary
Compare the clinical benefits and tolerability of these regimens in these patients
Compare the progression-free and overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to the participating center and ECOG performance status 0 or 1 vs 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2
Arm II Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on day 1
In both arms treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SANOFI-GERCOR-D04-1-GEMOX | None | None | None |
| GERCOR-D04-1-GEMOX | None | None | None |
| EU-20569 | None | None | None |