Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058149
Status:
COMPLETED
Last Update Posted:
2011-09-21
First Post:
2003-04-07
Brief Title:
Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Randomized Study of Gemcitabine Fixed-Dose Rate Infusion and Oxaliplatin NSC 266046 Versus Gemcitabine Fixed-Dose Rate Infusion Versus Gemcitabine 30-Minute Infusion in Pancreatic Carcinoma
Status:
COMPLETED
Status Verified Date:
2004-04
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:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as gemcitabine and oxaliplatin use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and giving them in different ways may kill more tumor cells It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic cancer
PURPOSE Randomized phase III trial to compare the effectiveness of gemcitabine with or without oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer
PURPOSE Randomized phase III trial to compare the effectiveness of gemcitabine with or without oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer
Detailed Description:
OBJECTIVES
Compare survival of patients with locally advanced or metastatic pancreatic cancer treated with prolonged infusion gemcitabine with vs without oxaliplatin vs standard infusion gemcitabine
Compare the toxicity of these regimens in these patients
Compare the objective response in patients treated with these regimens
Compare the patterns of failure and progression-free survival of patients treated with these regimens
Compare the reported frequency of deep vein thrombosis and pulmonary embolism among patients treated with these regimens
Compare the changes in quality of life including improved symptom control andor additional side effects of patients treated with these regimens
OUTLINE This is a multicenter study Patients are stratified according to ECOG performance status 0 or 1 vs 2 and disease stage locally advanced vs metastatic Patients are randomized to 1 of 3 treatment arms
Arm I standard treatment Patients receive gemcitabine IV over 30 minutes once weekly for 7 weeks followed by 1 week of rest for course 1 only In all subsequent courses patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 with courses repeating every 4 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 150 minutes on days 1 8 and 15 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Arm III Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 120 minutes on day 2 Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then at 8 and 16 weeks
Patients are followed for 3 years
PROJECTED ACCRUAL A total of 789 patients 263 per treatment arm will be accrued for this study within 18 months
Compare survival of patients with locally advanced or metastatic pancreatic cancer treated with prolonged infusion gemcitabine with vs without oxaliplatin vs standard infusion gemcitabine
Compare the toxicity of these regimens in these patients
Compare the objective response in patients treated with these regimens
Compare the patterns of failure and progression-free survival of patients treated with these regimens
Compare the reported frequency of deep vein thrombosis and pulmonary embolism among patients treated with these regimens
Compare the changes in quality of life including improved symptom control andor additional side effects of patients treated with these regimens
OUTLINE This is a multicenter study Patients are stratified according to ECOG performance status 0 or 1 vs 2 and disease stage locally advanced vs metastatic Patients are randomized to 1 of 3 treatment arms
Arm I standard treatment Patients receive gemcitabine IV over 30 minutes once weekly for 7 weeks followed by 1 week of rest for course 1 only In all subsequent courses patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 with courses repeating every 4 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 150 minutes on days 1 8 and 15 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Arm III Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 120 minutes on day 2 Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then at 8 and 16 weeks
Patients are followed for 3 years
PROJECTED ACCRUAL A total of 789 patients 263 per treatment arm will be accrued for this study within 18 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 |
|---|---|---|---|
| ECOG-6201 | None | None | None |