Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385606
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2006-10-10
Brief Title:
Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC
Sponsor:
National Cancer Institute Naples
Organization:
National Cancer Institute Naples
Study Overview
Official Title:
Phase II-III Factorial Multicenter Randomized Trial Evaluating the Addition of Rofecoxib to Polycht With Cispatin and Gemcitabine and Fixed Dose Rate Infusion of Gem in Association With Cisplatin in 1st-line for Advanced NSCLC
Status:
COMPLETED
Status Verified Date:
2015-04
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:
The purpose of this study is to evaluate the tolerability and efficacy of the addition of rofecoxib to first-line chemotherapy and to evaluate the efficacy of prolonged continuous infusion of gemcitabine in combination with cisplatin in the treatment of patients affected by advanced non-small cell lung cancer
Detailed Description:
The primary end-points of the GECO study
To evaluate the tolerability of three innovative schedules of treatment for advanced NSCLC
To evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy in the treatment of patients affected by advanced NSCLC
To evaluate the efficacy of prolonged continuous infusion pci of gemcitabine with the fixed infusion rate of 10 mgsqmminute versus the standard administration in 30 minutes in combination with cisplatin in the treatment of patients affected by advanced NSCLC
Four treatment arms are planned
ARM A standard treatment cisplatin gemcitabine
ARM B cisplatin gemcitabine rofecoxib
ARM C cisplatin pci gemcitabine 10 mgsqmminute
ARM D cisplatin pci gemcitabine 10 mgsqmminute rofecoxib
The phase II part of the study for experimental arms B C and D will be conducted to evaluate tolerability in the three treatment arms
The phase III study for efficacy has been designed according to a factorial 2x2 model with the planned comparison of
The efficacy of rofecoxib A C arms without rofecoxib vs BD arms with rofecoxib
The efficacy of pci gemcitabine A B arms with standard infusion of gemcitabine vs C D arms with pci gemcitabine
To evaluate the tolerability of three innovative schedules of treatment for advanced NSCLC
To evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy in the treatment of patients affected by advanced NSCLC
To evaluate the efficacy of prolonged continuous infusion pci of gemcitabine with the fixed infusion rate of 10 mgsqmminute versus the standard administration in 30 minutes in combination with cisplatin in the treatment of patients affected by advanced NSCLC
Four treatment arms are planned
ARM A standard treatment cisplatin gemcitabine
ARM B cisplatin gemcitabine rofecoxib
ARM C cisplatin pci gemcitabine 10 mgsqmminute
ARM D cisplatin pci gemcitabine 10 mgsqmminute rofecoxib
The phase II part of the study for experimental arms B C and D will be conducted to evaluate tolerability in the three treatment arms
The phase III study for efficacy has been designed according to a factorial 2x2 model with the planned comparison of
The efficacy of rofecoxib A C arms without rofecoxib vs BD arms with rofecoxib
The efficacy of pci gemcitabine A B arms with standard infusion of gemcitabine vs C D arms with pci gemcitabine
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