Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145418
Status:
TERMINATED
Last Update Posted:
2014-06-30
First Post:
2005-09-01
Brief Title:
Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer
Sponsor:
Oncology Specialists SC
Organization:
Oncology Specialists SC
Study Overview
Official Title:
Phase 2 Study Evaluating the Safety and Efficacy of Eloxatin Oxaliplatin and Docetaxel as First-line Therapy of Stage IV or IIIB Unresectable Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It has been accepted and proven that patients with unresectable lung cancer can benefit from systemic chemotherapy Traditional platinum-based therapy has significant side effects Oxaliplatin and docetaxel have both shown to be effective for lung cancer The purpose of this study is to determine if oxaliplatin combined with docetaxel has a lower toxicity profile and to determine the response rate to this study drug combination
Detailed Description:
This study is a Phase II study designed to evaluate the toxicity profile for oxaliplatin and docetaxel and to determine the response rate to this study drug combination The primary objective of the study is response rate by RECIST criteria The secondary objective is time to progression duration of response and toxicity Patients will receive
oxaliplatin 85mgm2 over 2 hours on Days 1 and 15
docetaxel 30mgm2 on Days 1 and 8
Cycles are to be repeated every 28 days for a maximum of 6 cycles
oxaliplatin 85mgm2 over 2 hours on Days 1 and 15
docetaxel 30mgm2 on Days 1 and 8
Cycles are to be repeated every 28 days for a maximum of 6 cycles
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