Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026338
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
2001-11-09
Brief Title:
Gemcitabine WithOut Erlotinib in Unresectable Locally AdvancedMetastatic Pancreatic Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Randomized Placebo Controlled Study Of OSI-774 TARCEVA Plus Gemcitabine In Patients With Locally Advanced Unresectable Or Metastatic Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2020-03
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:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Biological therapies such as erlotinib use different ways to stimulate the immune system and stop cancer cells from growing Combining chemotherapy and biological therapy may kill more tumor cells It is not yet known if gemcitabine is more effective with or without erlotinib in treating pancreatic cancer
PURPOSE Randomized phase III trial to determine the effectiveness of gemcitabine with and without erlotinib in treating patients who have unresectable locally advanced or metastatic pancreatic cancer
PURPOSE Randomized phase III trial to determine the effectiveness of gemcitabine with and without erlotinib in treating patients who have unresectable locally advanced or metastatic pancreatic cancer
Detailed Description:
OBJECTIVES
Compare the overall survival rate in patients with unresectable locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without erlotinib
Compare the progression-free survival rate in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare the response rate and response duration in patients treated with these regimens
Compare the nature severity and frequency of toxic effects of these regimens in these patients
Correlate the expression of tissue epidermal growth factor receptor levels at diagnosis with outcome and response in patients treated with these regimens
Determine the pharmacokinetics of erlotinib in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center extent of disease locally advanced vs metastatic and ECOG performance status 0-1 vs 2 Patients are randomized to one of two treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 8 15 22 29 36 and 43 of course 1 only which lasts 8 weeks and on days 1 8 and 15 of all subsequent courses which last 4 weeks each Patients also receive 1 of 2 doses of oral erlotinib once daily
Arm II Patients receive gemcitabine as in arm I and 1 of 2 doses of oral placebo once daily
Treatment continues in both arms in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline on day 29 of course 1 on day 1 of all subsequent courses at 4 weeks after study and then every 12 weeks until disease progression
Patients are followed at 4 weeks and then every 12 weeks thereafter
PROJECTED ACCRUAL A total of 800 patients 400 per treatment arm will be accrued for this study within 11 months
Compare the overall survival rate in patients with unresectable locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without erlotinib
Compare the progression-free survival rate in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare the response rate and response duration in patients treated with these regimens
Compare the nature severity and frequency of toxic effects of these regimens in these patients
Correlate the expression of tissue epidermal growth factor receptor levels at diagnosis with outcome and response in patients treated with these regimens
Determine the pharmacokinetics of erlotinib in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center extent of disease locally advanced vs metastatic and ECOG performance status 0-1 vs 2 Patients are randomized to one of two treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 8 15 22 29 36 and 43 of course 1 only which lasts 8 weeks and on days 1 8 and 15 of all subsequent courses which last 4 weeks each Patients also receive 1 of 2 doses of oral erlotinib once daily
Arm II Patients receive gemcitabine as in arm I and 1 of 2 doses of oral placebo once daily
Treatment continues in both arms in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline on day 29 of course 1 on day 1 of all subsequent courses at 4 weeks after study and then every 12 weeks until disease progression
Patients are followed at 4 weeks and then every 12 weeks thereafter
PROJECTED ACCRUAL A total of 800 patients 400 per treatment arm will be accrued for this study within 11 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069020 | OTHER | PDQ | None |
| CAN-NCIC-PA3 | OTHER | None | None |
| OSI-CAN-NCIC-PA3 | OTHER | None | None |