Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351039
Status:
TERMINATED
Last Update Posted:
2017-03-23
First Post:
2006-07-11
Brief Title:
Phase III Trial of Bevacizumab Pemetrexed and Erlotinib in Elderly Patients With Non-Small Cell Lung Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase III Trial of Bevacizumab Pemetrexed and Erlotinib in the First-Line Treatment of Elderly Patients With Advanced Stage IIIBWith Malignant Pleural Effusion or IV Non-Squamous Non-Small Cell Lung Cancer NSCLC
Status:
TERMINATED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase III trial of elderly patients 70 years of age Patients in this age group with previously un-treated Advanced Stage Non-Squamous Non-Small Cell Lung Cancer NSCLC with Stage IIIB with malignant pleural effusion and stage IV disease will be enrolled Therapy consists of three drugs PremetrexedAlimta Bevacizumab and ErlotinibTarceva which are given every 28 days
Detailed Description:
This is a Phase III trial of elderly patients 70 years of age with previously un-treated Advanced Stage Non-Squamous NSCLC with Stage IIIB with malignant pleural effusion and stage IV disease will be enrolled
Treatment Regimen
Premetrexed Alimta 500 milligramsmgMeter squaredm20 IntravenousIV Day 1 and Day 15 Bevacizumab 10mgKilogramKg I V Day 1 and Day 15 Erlotinib Tarceva 150mg Per OrallyPO Once DailyQD for 7 days starting day 2 and day 15 Repeat cycles every 28 days
All three drugs will be continued for two cycles after maximal response After which patient will be maintained only on the Bevacizumab and Erlotinib until progression If patient has stable disease after the first two cycles then patient will be given another two cycles with all three drugs before maintenance treatment with Bevacizumab and Erlotinib is initiated
Treatment Regimen
Premetrexed Alimta 500 milligramsmgMeter squaredm20 IntravenousIV Day 1 and Day 15 Bevacizumab 10mgKilogramKg I V Day 1 and Day 15 Erlotinib Tarceva 150mg Per OrallyPO Once DailyQD for 7 days starting day 2 and day 15 Repeat cycles every 28 days
All three drugs will be continued for two cycles after maximal response After which patient will be maintained only on the Bevacizumab and Erlotinib until progression If patient has stable disease after the first two cycles then patient will be given another two cycles with all three drugs before maintenance treatment with Bevacizumab and Erlotinib is initiated
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