Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT00145418
Status:
TERMINATED
Last Update Posted:
2014-06-30
First Post:
2005-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer
Sponsor:
Oncology Specialists, S.C.
Organization:
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 85mg/m2 over 2 hours on Days 1 and 15
* docetaxel 30mg/m2 on Days 1 and 8
Cycles are to be repeated every 28 days for a maximum of 6 cycles.
* oxaliplatin 85mg/m2 over 2 hours on Days 1 and 15
* docetaxel 30mg/m2 on Days 1 and 8
Cycles are to be repeated every 28 days for a maximum of 6 cycles.
Study Oversight
Has Oversight DMC:
False
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?: