Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434135
Status:
COMPLETED
Last Update Posted:
2009-02-05
First Post:
2007-02-09
Brief Title:
Alimta and Gemcitabine in Non-Small Cell Lung Cancer
Sponsor:
Southern Italy Cooperative Oncology Group
Organization:
Southern Italy Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Randomized Trial Assessing the Combination of Gemcitabine and Pemetrexed in the First Line Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2009-02
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:
ANGEL
Brief Summary:
The aims of this study are 1 to assess the safety and activity of gemcitabine plus Alimta pemetrexed regimen GA regimen in patients with advanced NSCLC patients in the context of a randomized trial and 2 to compare the GA with the paclitaxel plus gemcitabine PG regimen in terms of toxicity and QoL
Detailed Description:
Patients with stage IIIB or IV non-small cell lung cancer will be randomly allocated to receive aPG regimen paclitaxel 120 mgsqm followed by gemcitabine 1000 mgsqm iv on days 1 8 q 3 weeks bGA regimen gemcitabine 1250 mgsqm iv on day 1 plus folinic acid 350 μg daily orally and vitamin B12 1000 μg im q 9 weeks pemetrexed Alimta 500 mgsqm iv on day 8 followed by gemcitabine 1250 mgsqm q 3 weeks
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