Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075452
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2004-01-09
Brief Title:
Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma
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 tumor cells from dividing so they stop growing or die It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma
PURPOSE This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma
PURPOSE This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma
Detailed Description:
OBJECTIVES
Primary
Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin
Secondary
Compare the time of response in patients treated with these regimens
Compare the clinical benefit of and tolerance to these regimens in these patients
Compare the quality of life of patients treated with these regimens
Compare the progression-free survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center ECOG performance status 0 or 1 vs 2 and extent of disease locally advanced vs metastatic Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and 9-11 in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2 Courses repeat every 14 days for up to 3 months in the absence of disease progression or unacceptable toxicity
After the completion of chemotherapy patients with locally advanced disease receive chemoradiotherapy
Quality of life is assessed at baseline and then every 2 months
PROJECTED ACCRUAL A total of 230 patients 115 per treatment arm will be accrued for this study within 24 months
Primary
Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin
Secondary
Compare the time of response in patients treated with these regimens
Compare the clinical benefit of and tolerance to these regimens in these patients
Compare the quality of life of patients treated with these regimens
Compare the progression-free survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center ECOG performance status 0 or 1 vs 2 and extent of disease locally advanced vs metastatic Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and 9-11 in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2 Courses repeat every 14 days for up to 3 months in the absence of disease progression or unacceptable toxicity
After the completion of chemotherapy patients with locally advanced disease receive chemoradiotherapy
Quality of life is assessed at baseline and then every 2 months
PROJECTED ACCRUAL A total of 230 patients 115 per treatment arm will be accrued for this study within 24 months
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 |
|---|---|---|---|
| FRE-GERCOR-GEM-GEMOXD00-3 | None | None | None |
| EU-20324 | None | None | None |